Duns Number:188582360
Device Description: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-
Catalog Number
27504-01
Brand Name
SurgiWrap
Version/Model Number
130 x 200 x 0.05mm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
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,K050332
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
c3790f0b-a547-4750-b79e-d43c53defc25
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 10, 2020
Package DI Number
00810057380204
Quantity per Package
5
Contains DI Package
00810057380198
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
5 unit box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |