Duns Number:811313428
Device Description: ATRAMAT PDX SURGICAL SUTURE VIOLET USP 3-0 EP 2, 90 CM NEEDLE P-26 PREMIUM REVERSE CUTTI ATRAMAT PDX SURGICAL SUTURE VIOLET USP 3-0 EP 2, 90 CM NEEDLE P-26 PREMIUM REVERSE CUTTING 26 MM 1/2 CIRCLE
Catalog Number
P2673-90
Brand Name
ATRAMAT
Version/Model Number
POLIDIOXANONA
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
K041048,K041048
Product Code
NEW
Product Code Name
Suture, Surgical, Absorbable, Polydioxanone
Public Device Record Key
baa6e170-cfea-443d-be23-4add38117b40
Public Version Date
May 04, 2022
Public Version Number
1
DI Record Publish Date
April 26, 2022
Package DI Number
07500142161728
Quantity per Package
12
Contains DI Package
07500142061721
Package Discontinue Date
-
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 |