Duns Number:943130096
Device Description: Barrier, Absorbable, Adhesion
Catalog Number
-
Brand Name
Seprafilm® Procedure Pack
Version/Model Number
5086-02
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
-
Product Code
MCN
Product Code Name
BARRIER, ABSORABLE, ADHESION
Public Device Record Key
98eaa8a8-5b49-4ae4-a57a-48727fe71263
Public Version Date
June 19, 2020
Public Version Number
6
DI Record Publish Date
September 24, 2014
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 3 | A medical device with high risk that requires premarket approval | 3 |