Duns Number:811313428
Device Description: ATRAMAT PLAIN GUT SURGICAL SUTURE USP 4-0 EP 2, 150 CM NEEDLE EZ-SS0-0 WITHOUT NEEDLE EASY ATRAMAT PLAIN GUT SURGICAL SUTURE USP 4-0 EP 2, 150 CM NEEDLE EZ-SS0-0 WITHOUT NEEDLE EASY PULL 0 MM CATGUT SIMPLE USP 4-0, 150 CM SIN AGUJA EASY PULL 12 SOBRES
Catalog Number
EZ-SS0024-150
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
e545e9f7-041c-4689-9462-6be5a62bff42
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
July 31, 2018
Package DI Number
07500142180453
Quantity per Package
12
Contains DI Package
07500142080456
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 |