Duns Number:811313428
Device Description: ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 4-0 EP 2, 75 CM NEEDLE CE-19 REVERSE CUTTING 19 MM ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 4-0 EP 2, 75 CM NEEDLE CE-19 REVERSE CUTTING 19 MM 3/8 CIRCLE
Catalog Number
CE1914-75
Brand Name
ATRAMAT
Version/Model Number
CHROMIC GUT
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"
-
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
bcbd1945-1204-40d2-b204-2b1f65783be7
Public Version Date
March 16, 2021
Public Version Number
1
DI Record Publish Date
March 08, 2021
Package DI Number
07500142101816
Quantity per Package
12
Contains DI Package
07500142001819
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 |