Duns Number:188582360
Device Description: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide- 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.
Catalog Number
27201-01
Brand Name
SurgiWrap®
Version/Model Number
50 x 70 x 0.02mm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 10, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K050332
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
6fba9d8c-d440-45ba-97c9-a168b0af8257
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
October 23, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |