Duns Number:811313428
Device Description: ATRAMAT PLAIN GUT SURGICAL SUTURE USP 4-0 EP 2, 75 CM NEEDLE PE-19 PREMIUM REVERSE CUTTING ATRAMAT PLAIN GUT SURGICAL SUTURE USP 4-0 EP 2, 75 CM NEEDLE PE-19 PREMIUM REVERSE CUTTING 19 MM 3/8 CIRCLECATGUT SIMPLE USP 4-0, 75 CM AGUJA PE-19 REVERSO CORTANTE PREMIUM 19 MM 3/8 CIRCULO
Catalog Number
PE1924-75
Brand Name
ATRAMAT
Version/Model Number
CATGUT SIMPLE
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
K911354,K911354
Product Code
GAI
Product Code Name
Stripper, Vein, Reusable
Public Device Record Key
10cb61e0-6a3b-4c56-9a3e-5704b8dabacb
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
July 13, 2018
Package DI Number
07500142156465
Quantity per Package
12
Contains DI Package
07500142056468
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 |