Duns Number:069277028
Device Description: 3/8 Circle Reverse Cutting Needle (24.3mm), USP 4-0 SUPRAMID black monofilament Nylon, 70"
Catalog Number
Code MPL-40B-70
Brand Name
SUPRAMID
Version/Model Number
Code MPL-40B-70
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
ff6dfe74-92d0-4af0-8689-9dcbce614746
Public Version Date
July 01, 2022
Public Version Number
1
DI Record Publish Date
June 23, 2022
Package DI Number
10816848024064
Quantity per Package
12
Contains DI Package
00816848024067
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 183 |