Duns Number:480920383
Device Description: SURGICEL FIBRILLAR Absorbable Hemostats (oxidized regenerated cellulose)
Catalog Number
1961
Brand Name
SURGICEL FIBRILLAR
Version/Model Number
1961
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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,N12159,N12159,N12159,N12159,N12159,N12159
Product Code
LMG
Product Code Name
Agent, absorbable hemostatic, non-collagen based
Public Device Record Key
51288521-f790-41c3-942f-fb71affe7b22
Public Version Date
November 12, 2021
Public Version Number
10
DI Record Publish Date
September 20, 2014
Package DI Number
20705031003115
Quantity per Package
10
Contains DI Package
10705031003118
Package Discontinue Date
-
Package Status
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| 3 | A medical device with high risk that requires premarket approval | 11 |