Who else makes this device?

Name: Blue Sky Bio, LLC.
Brand: Blue Sky Bio, LLC.

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

Blue Sky Bio, LLC.

2 catalogue numbers from PG40FS2, listed by Blue SKY BIO, LLC, United States, under Suture, Absorbable, Synthetic, Polyglycolic Acid. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

2catalogue numbers in this listing

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 Blue Sky Bio, LLC.
Listed by	Blue SKY BIO, LLC, 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
510(k)	K073614
Record published	2015-10-23
Record revised	2019-10-18 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Carton of 12, case of 100

Catalogue Numbers

Catalogue numbers for Blue Sky Bio, LLC.
Catalogue number	Size	Status
PG40FS2		In distribution
PGF40FS2		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

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.