Duns Number:080194935
Device Description: Coated Polyglycolic Acid (PGA) Braided Absorbable Suture Violet, 3-0, 19mm, 3/8 reverse cu Coated Polyglycolic Acid (PGA) Braided Absorbable Suture Violet, 3-0, 19mm, 3/8 reverse cutting needle,
Catalog Number
-
Brand Name
GoldenDent
Version/Model Number
SPGA3
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
3eb09e9a-e8b7-4b9b-8e5d-00bd807e284c
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
December 11, 2019
Package DI Number
10817169022647
Quantity per Package
12
Contains DI Package
00817169022640
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |