Who else makes this device?

Name: SurgiWrap®
Brand: SurgiWrap®

General & Plastic Surgery › ProstheticMesh, Surgical, Polymeric

SurgiWrap®

Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). To be used wherever temporary wound support is required, to reinforce soft tissues…

Registry build 21.09.26

Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). To be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Minimizes tissue attachments to the device in case of direct contact with the viscera. Indicated for open and laparoscopic procedures.

1manufacturer

12catalogue numbers in this listing

3510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code FTL
Manufacturer	City	Province	Registered as	Device types
Shanghai Suokang Medical Implants Co., Ltd.	Shang Hai	Shanghai	Manufacturer	2

Record

Regulatory record for SurgiWrap®
Listed by	Mast Biosurgery USA Inc., United States
FDA product code	FTL
Device type	Mesh, Surgical, Polymeric
Device class	Class 2
Regulation	21 CFR 878.3300
Establishment	Manufacturer, Exporter
510(k)	K050332
Record published	2015-10-23
Record revised	2025-08-18 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 59 to 86 °F
Packaging	5 unit box of 5
Sizes	Length 70 to 280 mm; width 50 to 180 mm
Distribution end date	2020-11-10

Catalogue Numbers

Catalogue numbers for SurgiWrap®
Catalogue number	Size	Status
130 x 200 x 0.02mm	130mm x 200mm x 0.02mm	In distribution
100 x 130 x 0.05mm	100mm x 130mm x 0.05mm	In distribution
130 x 200 x 0.05mm	130mm x 200mm x 0.05mm	In distribution
100 x 130 x 0.02mm	100mm x 130mm x 0.02mm	In distribution
50 x 70 x 0.02mm	Thickness: 0.02 Millimeter	Withdrawn
180 x 280 x 0.05mm	Width 180 mm	Withdrawn
100 x 130 x 0.02mm	Thickness: 0.02 Millimeter	Withdrawn
50 x 70 x 0.05mm	Thickness: 0.05mm	Withdrawn
180 x 280 x 0.02mm	Thickness: 0.02 Millimeter	Withdrawn
100 x 130 x 0.05mm	Thickness: 0.05mm	Withdrawn
130 x 200 x 0.05mm	Thickness: 0.05mm	Withdrawn
130 x 200 x 0.02mm	Thickness: 0.02 Millimeter	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Technical Products	Technical Products, Inc.	143
Parietex	Sofradim Production	82
DynaMesh	FEG Textiltechnik Forschungs- und Entwicklungsges. mbH	45
Symbotex	Sofradim Production	35
Silicone Sheeting Reinforced	Bentec Medical OpCo, LLC.	33
Parietene	Sofradim Production	32
C-QUR	Atrium Medical Corporation	31
ProGrip	Sofradim Production	31
Silicone Sheeting Non-Reinforced	Bentec Medical OpCo, LLC.	31
Prolite	Atrium Medical Corporation	31
Gore Seamguard Bioabsorbable Staple Line Reinforce	W. L. Gore & Associates, Inc.	30
Surgimesh®wn	Aspide Medical	28

Showing 12 of 148. All products under Mesh, Surgical, Polymeric

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K063648	2007-03-07
K061473	2006-09-21
K050332	2005-05-27

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2014-08-26	Class II	Labeling Change Control	The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The printed expiration date was August of 2017, while the bar code date read as July 31, 2017. The correct expiration date	49 pieces	2015-02-24

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
P990028	2003-12-04	FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT	Genzyme Corporation

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.