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 for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. Minimizes tissue attachment to the device in case of direct contact with the tissues. Also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery. Reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient’s own soft tissue. The device is indicated for open and laparoscopic/endoscopic procedures.
Catalog Number
47201-01
Brand Name
OrthoWrap
Version/Model Number
50mm x 70mm x 0.02mm
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)
-
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
K072190,K072190
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
4d028eba-5434-4ea8-b471-2c2899b44739
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 10, 2020
Package DI Number
00810057380327
Quantity per Package
5
Contains DI Package
00810057380389
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 |