Duns Number:079932697
Device Description: Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 3/0, Reverse Cutting Needl Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 3/0, Reverse Cutting Needle, 19mm, 3/8 curvature, Sterile
Catalog Number
-
Brand Name
Golnit Nylon Monofilament Suture
Version/Model Number
NB2D3019-75
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
-
Product Code
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
e4f6ea00-7cae-4804-bdcc-b117bf7d140a
Public Version Date
September 26, 2022
Public Version Number
1
DI Record Publish Date
September 17, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 7 |