Duns Number:811313428
Device Description: ATRAMAT POLYESTER SURGICAL SUTURE GREEN USP 2-0 EP 3, 75 CM DOUBLE NEEDLE S-16 PREMIUM TAP ATRAMAT POLYESTER SURGICAL SUTURE GREEN USP 2-0 EP 3, 75 CM DOUBLE NEEDLE S-16 PREMIUM TAPER POINT 16 MM 1/2 CIRCLE KIT WITH PLEDGET WITH 6 POUCHES
Catalog Number
S1652/2-75KP6
Brand Name
ATRAMAT
Version/Model Number
POLYESTER
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
K905285,K905285
Product Code
GAS
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyester
Public Device Record Key
1e816984-3a2b-4ad9-958a-d68407fa7e0d
Public Version Date
March 16, 2021
Public Version Number
1
DI Record Publish Date
March 08, 2021
Package DI Number
07500142905049
Quantity per Package
60
Contains DI Package
07500142005046
Package Discontinue Date
December 31, 2040
Package Status
In Commercial Distribution
Package Type
BOX WITH 60 PACKS
| 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 |