Duns Number:480920383
Device Description: SURGICEL NU-KNIT Absorbable Hemostats (oxidized regenerated cellulose)
Catalog Number
1940
Brand Name
SURGICEL NU-KNIT
Version/Model Number
1940
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
Product Code
LMG
Product Code Name
Agent, absorbable hemostatic, non-collagen based
Public Device Record Key
296801cf-d51c-4387-8976-4810a57e8fcb
Public Version Date
November 12, 2021
Public Version Number
10
DI Record Publish Date
October 19, 2016
Package DI Number
20705031002958
Quantity per Package
24
Contains DI Package
10705031002951
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 |