Duns Number:811313428
Device Description: ATRAMAT PGA SURGICAL SUTURE VIOLET USP 1 EP 4, 70 CM NEEDLE SG-36 PREMIUM HEAVY TAPER POIN ATRAMAT PGA SURGICAL SUTURE VIOLET USP 1 EP 4, 70 CM NEEDLE SG-36 PREMIUM HEAVY TAPER POINT 36 MM 1/2 CIRCLEPGA VIOLETA USP 1, 70 CM AGUJA SG-36 AHUSADA GRUESA PREMIUM 36 MM 1/2 CIRCULO
Catalog Number
SG3698
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"
-
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
b0fc4eee-8af1-4332-b406-ac848ae58d65
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
October 18, 2016
Package DI Number
07500142154911
Quantity per Package
12
Contains DI Package
07500142054914
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 |