Duns Number:811313428
Device Description: ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 5-0 EP 1,5, 45 CM DOUBLE NEEDLE P-PE-13 SUPRA-SHAR ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 5-0 EP 1,5, 45 CM DOUBLE NEEDLE P-PE-13 SUPRA-SHARP REVERSE CUTTING 13 MM 3/8 CIRCLECATGUT CROMICO USP 5-0, 45 CM DOBLE AGUJA P-PE-13 REVERSO CORTANTE SUPRA-SHARP 13 MM 3/8 CIRCULO
Catalog Number
P-PE1315/2
Brand Name
ATRAMAT
Version/Model Number
CATGUT CROMICO
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
370136c2-cbf6-48a3-8999-4ed8b2042351
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
July 11, 2018
Package DI Number
07500142155741
Quantity per Package
12
Contains DI Package
07500142055744
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 |