Duns Number:829465157
Device Description: Surgicel Fibrillar Absorbable Hemostat
Catalog Number
431961
Brand Name
SURGICEL FIBRILLAR
Version/Model Number
431961
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 18, 2020
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
N12159,N12159
Product Code
LMG
Product Code Name
Agent, absorbable hemostatic, non-collagen based
Public Device Record Key
cd36e16f-ef9c-4d30-8266-a0e733b91255
Public Version Date
December 18, 2020
Public Version Number
9
DI Record Publish Date
September 20, 2014
Package DI Number
20705031005355
Quantity per Package
10
Contains DI Package
10705031005358
Package Discontinue Date
December 18, 2020
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1028 |
| 3 | A medical device with high risk that requires premarket approval | 15 |
| U | Unclassified | 1 |