Duns Number:002348191
Device Description: RC SLK BK BR 1 24"X12
Catalog Number
S-926
Brand Name
DEKNATEL
Version/Model Number
IPN025494
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"
Yes
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
GAP
Product Code Name
SUTURE, NONABSORBABLE, SILK
Public Device Record Key
d2fc4862-2043-46fc-a543-638a84ef647b
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
October 23, 2015
Package DI Number
24026704424348
Quantity per Package
12
Contains DI Package
04026704424344
Package Discontinue Date
May 08, 2017
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3195 |
2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
3 | A medical device with high risk that requires premarket approval | 3 |
U | Unclassified | 26 |