Duns Number:078273228
Device Description: Coated Polyglycolic Acid (PGA) Braided Absorbable Suture Violet, 4-0, 19mm, 3/8 reverse cu Coated Polyglycolic Acid (PGA) Braided Absorbable Suture Violet, 4-0, 19mm, 3/8 reverse cutting needle, Qty 12
Catalog Number
SPGA4
Brand Name
GoldenDent
Version/Model Number
SPGA4
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K073614,K073614
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
267a3d9d-8b4e-4811-8f98-b8c3b30f543e
Public Version Date
March 05, 2021
Public Version Number
1
DI Record Publish Date
February 25, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 145 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |