Duns Number:073436164
Device Description: Polypropylene Suture, 4-0, C3 Needle
Catalog Number
-
Brand Name
IMCO
Version/Model Number
8699-IMC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAW
Product Code Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Public Device Record Key
f1a84288-9fe5-4d4a-b22b-e243808c9016
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
June 13, 2016
Package DI Number
10815842021574
Quantity per Package
12
Contains DI Package
00815842021577
Package Discontinue Date
-
Package Status
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 42 |