Duns Number:594540572
Device Description: Endoform Surface is intended for applications in plastic and reconstructive surgery or to Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover, protect, and provide a moist wound environment. The device may be fixed, via sutures, staples, or tacks to the surrounding tissue, if desired.
Catalog Number
-
Brand Name
Endoform Surface
Version/Model Number
SR05LG1010
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2019
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
K162461,K171231
Product Code
FTM
Product Code Name
Mesh, Surgical
Public Device Record Key
172d0fb4-4296-4656-a56e-bd83b92104c3
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
July 02, 2018
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. | 135 |
| U | Unclassified | 33 |