Duns Number:005083209
Device Description: Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion ba Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC).
Catalog Number
664201
Brand Name
SEPRAFILM
Version/Model Number
664201
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
P950034,P950034,P950034
Product Code
MCN
Product Code Name
Barrier, absorbable, adhesion
Public Device Record Key
42aa024b-d8fc-47cf-8d42-37d41c994ad3
Public Version Date
October 11, 2022
Public Version Number
2
DI Record Publish Date
June 10, 2021
Package DI Number
35413765589622
Quantity per Package
10
Contains DI Package
05413765589621
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |