Duns Number:080194935
Device Description: Blue Nylon Monofilament Sutures 3/0 3/8cut 24mm
Catalog Number
-
Brand Name
Basik
Version/Model Number
BN663
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"
-
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
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
c21370de-528f-4047-9b55-3bfa06aaf2a3
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
November 27, 2020
Package DI Number
10817169023033
Quantity per Package
12
Contains DI Package
00817169023036
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 142 |
U | Unclassified | 1 |