PRODUCT INFORMATION - SURGICAL PRODUCTS
Q: What is the classification of G.O.L.F.F.?
A:

EEC Classification: Class IIa, rule 6 of annex 9 of the 93/42/ECC dated June 14, 1993, including the 2007/47/EEC amendments, as it is a surgically invasive device intended for a transient use.
CMDR: Class 2, Schedule 1, Part 1, rule 1(1)
Q: Does the GOLFF™ Anti-Fog Solution contain any alcohol?
A: Yes, the solution contains 4.5% of Isopropyl Alcohol. The product is a clear, colorless liquid,
with an alcoholic odor.
Q:

What is the intended use of G.O.L.F.F.?

A:

G.O.L.F.F. is a sterile and latex free anti-fog solution used to put on the lenses of endoscopic and laparoscopic cameras.  It is composed of an easy to squeeze bottle and a sponge used for secure placement. It is used as an anti-for agent for endoscopic camera lenses.
Q: What is the intended use of the Cautery Tip Cleaner?
A:

The Cautery Tip Cleaner is a single use device intended to assist in cleaning and removing material from cautery tips during surgical procedures.
Q: What is the classification of the Cautery Tip Cleaner?
A: EEC Classification Rule: Rule 1 of Annex IX from EEC, Product Class: I non invasive device
Q: Are the Sterile Cautery Tip Cleaners (60-10200) available yet?
A:

No, they will be available in the latter half of 2010. These products are however currently available in a non-sterile format (60-10000 and 60-10100).
Q:

Is each unit of the Sterile Multi-Tip Fine Marker individually packaged?
A:

Yes, each sterile unit is individually packaged.
Q:

Where can I find information on Batrik Medical Manufacturing Inc.’s registration and device listing with the FDA?
A: Please visit: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
Q:

What is the intended use of the Vascular Silicone Ties?
A:

The intended use of the Vascular Silicone Tie is to occlude vessels during a surgical operation.
Q:

What is the classification of the Vascular Silicone Ties?
A:

EEC Classification: IIa, as the Vascular Silicone Ties are surgically invasive devices intended for a transient use. Rule 6 of Annex IX of the 93/42/EEC, June 14, 1993, including the 2007/47/EEC amendments. CMDR Classification: II, Schedule 1, Part 1, Rule 1 (1), of the MDR, May 7, 1998. Due to the fact that Clamp Jaw Covers are a surgically invasive device.
Q: What is the intended use of the Clamp Jaw Cover?
A:

The Clamp Jaw Covers are to be used as a cover placed over the jaws of instruments in order to reduce trauma to vessels.
Q:

What is the classification of the Clamp Jaw Cover?
A:

EEC Classification: IIa, due to the fact that the Clamp Jaw Covers are a surgically invasive device intended for transient use. Rule 6 of Annex IX of the 93/42/EEC, June 14, 1993, including the 2007/47/EEC amendments. CMDR Classification: II, Schedule 1, Part 1, Rule 1 (1), of the MDR, May 7, 1998. Due to the fact that Clamp Jaw Covers are a surgically invasive device.
Q: What is the intended use of SKINS™?
A:

SKINS™ are a pen-shaped medical device used by surgeons to effectively mark an incision site, on the patient's skin prior to or during a surgical procedure. They can also be used to mark drapes.
Q:

What is the classification of SKINS™?
A:

EEC Classification Rule: Rule 1 of Annex IX from European Council Directive 93/24/EEC, including the 2007/47/EEC amendments. Product Class: I (sterile) non invasive device used with intact skin. CMDR: Class I, Schedule 1, Part 1, rule 7 (1).
Q: What is the intended use of the Suture Clamp Tags?
A: The intended use of the Suture Clamp Tag is to protect, hold and identify sutures outside of the body.
Q: The intended use of the Suture Clamp Tag is to protect, hold and identify sutures outside of the body.
A: EEC Classification: IS because it is a non invasive sterile device. Rule 1 of Annex IX of the
93/42/EEC, June 14, 1993, including the 2007/47/EEC amendments.
CMDR Classification: I, Schedule 1, Part 1, Rule 7 (1), of the MDR, May 7, 1998.