Duns Number:811313428
Device Description: ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 4-0 EP 2, 30 CM DOUBLE NEEDLE EA-9 PREMIUM SPAT ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 4-0 EP 2, 30 CM DOUBLE NEEDLE EA-9 PREMIUM SPATULA 9 MM 1/4 CIRCLE
Catalog Number
EA914/2-30
Brand Name
ATRAMAT
Version/Model Number
CATGUT CROMICO
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
K911354,K911354
Product Code
GAL
Product Code Name
Suture, Absorbable, Natural
Public Device Record Key
5974c903-f09a-4c3d-9326-07a817bb58cc
Public Version Date
May 04, 2022
Public Version Number
1
DI Record Publish Date
April 26, 2022
Package DI Number
07500142103476
Quantity per Package
12
Contains DI Package
07500142003479
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 |