Who else makes this device?

Name: Sutrazorb
Brand: Sutrazorb

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

Sutrazorb

8-0 Suture USP / Thread Specifications: PGA, 12 inch (30 cm) / Needle Specifications: ST-140-8, Spatula Tip, 3/8 (140 degrees), length 6.0mm, wire diameter 0.20 mm / # of needles: Double arm

Registry build 21.09.26

4manufacturers in China registered for this device type

7catalogue 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 Sutrazorb
Listed by	Visionary Medical Supplies, Inc., United States
FDA product code	GAM
Device type	Suture, Absorbable, Synthetic, Polyglycolic Acid
Device class	Class 2
Regulation	21 CFR 878.4493
Establishment	Specification developer, Manufacturer, Exporter
Record published	2016-05-13
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: Keep away from Moisture, chemicals, oxides, and direct heat.; Storage environment temperature up to 25 °C
Packaging	Carton of 12, pouch
Sizes	Angle 90 to 160 °; outer diameter 0.2 to 0.23 mm; length 13 to 45 cm; length 6 to 8 mm
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Sutrazorb
Catalogue number	Size	Status
A74092	Angle 140 °	In distribution
A69092	6-0 USP	In distribution
A66092	Outer Diameter 0.23 mm	In distribution
A84082	Double Arm	In distribution
A69082-1	Angle 90 °	In distribution
A74092-1	Length 6.5 mm	In distribution
A84082TP	Outer Diameter 0.20 mm	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
K102592	2011-02-03

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.