Duns Number:812762226
Device Description: DDK-11.0-300 USP 6/0 PGA violet 45 cm. sterile VA17.1
Catalog Number
-
Brand Name
FSSB
Version/Model Number
D047PGA
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
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
b5a6729a-5e73-4c1e-96a6-5d4eb20c3122
Public Version Date
August 09, 2022
Public Version Number
1
DI Record Publish Date
August 01, 2022
Package DI Number
10848782039088
Quantity per Package
12
Contains DI Package
00848782039081
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 | 300 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2030 |
| U | Unclassified | 19 |