Duns Number:811313428
Device Description: ATRAMAT NYLON SURGICAL SUTURE BLACK USP 6-0 EP 0.7, 45 CM NEEDLE P-PE-11 SUPRA-SHARP REVER ATRAMAT NYLON SURGICAL SUTURE BLACK USP 6-0 EP 0.7, 45 CM NEEDLE P-PE-11 SUPRA-SHARP REVERSE CUTTING 11 MM 3/8 CIRCLENYLON NEGRO USP 6-0, 45 CM AGUJA P-PE-11 REVERSO CORTANTE SUPRA-SHARP 11 MM 3/8 CIRCULO
Catalog Number
P-PE1146-N
Brand Name
ATRAMAT
Version/Model Number
NYLON
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
K905286,K905286
Product Code
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
d460a608-4743-4a2f-9ae6-a5f77083cdc7
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
October 17, 2016
Package DI Number
07500142145728
Quantity per Package
12
Contains DI Package
07500142045721
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 |