Who else makes this device?

Name: Polycryl
Brand: Polycryl

General & Plastic Surgery › SurgicalSuture, Absorbable, Synthetic, Polyglycolic Acid

Polycryl

Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A6409 model consists of a 6/0 PGA suture of length 45cm attached…

Registry build 21.09.26

Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A6409 model consists of a 6/0 PGA suture of length 45cm attached with two 510 microns SS needles having the needle length of 20.0mm in one end of suture. Angle of curvature of both the needles are 135° [3/8 Circle]. Point profile of needle is Conventional Cutting.

4manufacturers in China registered for this device type

5catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1), Beijing (1).

Chinese manufacturers registered for FDA product code GAM
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Foosin Medical Supplies Inc.ltd	Weihai	Shandong	Manufacturer	8
ARC Medical Supplies (Beijing) Co., Ltd.	Beijing	Beijing	Manufacturer	7
Sichuan Innovation Technology Co., Ltd.	Chengdu	Sichuan	Contract manufacturer	2

Record

Regulatory record for Polycryl
Listed by	Aurolab, India
FDA product code	GAM
Device type	Suture, Absorbable, Synthetic, Polyglycolic Acid
Device class	Class 2
Regulation	21 CFR 878.4493
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
510(k)	K140039
Record published	2020-09-16
Record revised	2021-02-05 (version 2)

Specifications

Specifications
MRI safety	MR Safe
Supplied sterile	Yes
Single use	Yes
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Handling environment temperature 2 to 40 °C
Packaging	Box of 12

Catalogue Numbers

Catalogue numbers for Polycryl
Catalogue number	Size	Status
A7102		In distribution
A6108		In distribution
A6409		In distribution
A5108		In distribution
A8104		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Novosyn	B Braun Surgical SA	2,286
DemeCRYL	Demetech Corp.	2,092
DemeSORB	Demetech Corp.	1,625
Safil	B Braun Surgical SA	1,613
Monosyn	B Braun Surgical SA	1,096
E-Pack	Ethicon, Inc.	967
Coated Vicryl	Ethicon, Inc.	933
DemeQUICK	Demetech Corp.	732
Polysorb	Covidien LP	732
DemeCAPRONE	Demetech Corp.	707
Wego-PGA Absorbable Surgical Suture With Needle	Foosin Medical Supplies Inc.ltd	554
Safil Quick+	B Braun Surgical SA	414

Showing 12 of 463. All products under Suture, Absorbable, Synthetic, Polyglycolic Acid

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K140039	2014-09-15

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P840051	1989-06-07	MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU	Davis & Geck, Inc.
N18387	1987-06-18	PDS(TM) SUTURE (CLEAR)	Ethicon, Inc.
N16881	1981-12-04	DEXON	Davis & Geck, Inc.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.