Duns Number:096372255
Device Description: SUTURE SILK BRD BLACK C-1SZ 5-0 30 IN
Catalog Number
99-0213
Brand Name
DeRoyal
Version/Model Number
99-0213
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
K012124,K012124
Product Code
GAP
Product Code Name
SUTURE, NONABSORBABLE, SILK
Public Device Record Key
981b18ea-144a-48b4-8085-81d2a32ff645
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
November 09, 2019
Package DI Number
50749756998852
Quantity per Package
1
Contains DI Package
00749756998857
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 | 7041 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
| U | Unclassified | 3 |