Duns Number:811313428
Device Description: ATRAMAT NYLON SURGICAL SUTURE BLACK USP 0 EP 3,5, 45 CM NEEDLE CE-19 REVERSE CUTTING 19 ATRAMAT NYLON SURGICAL SUTURE BLACK USP 0 EP 3,5, 45 CM NEEDLE CE-19 REVERSE CUTTING 19 MM 3/8 CIRCLE
Catalog Number
CE1941-N
Brand Name
ATRAMAT
Version/Model Number
NYLON
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
K905286,K905286
Product Code
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
27c82374-fe4f-44da-958e-fd17101dea9e
Public Version Date
May 04, 2022
Public Version Number
1
DI Record Publish Date
April 26, 2022
Package DI Number
07500142180828
Quantity per Package
12
Contains DI Package
07500142180811
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 |