Duns Number:811313428
Device Description: ATRAMAT PGA SURGICAL SUTURE VIOLET USP 0 EP 3,5, 75 CM NEEDLE G-37 HEAVY TAPER POINT 37 ATRAMAT PGA SURGICAL SUTURE VIOLET USP 0 EP 3,5, 75 CM NEEDLE G-37 HEAVY TAPER POINT 37 MM 1/2 CIRCLEPGA VIOLETA USP 0, 75 CM AGUJA G-37 AHUSADA GRUESA 37 MM 1/2 CIRCULO
Catalog Number
G3791-75
Brand Name
ATRAMAT
Version/Model Number
PGA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2040
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
K040282,K040282
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
6cbe9f4c-312e-4c8d-8570-6f0f10eccc8c
Public Version Date
August 06, 2018
Public Version Number
1
DI Record Publish Date
July 06, 2018
Package DI Number
07500142100499
Quantity per Package
12
Contains DI Package
07500142000492
Package Discontinue Date
December 31, 2040
Package Status
In Commercial Distribution
Package Type
DOZEN
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 44 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 830 |