Duns Number:811313428
Device Description: ATRAMAT POLYESTER SURGICAL SUTURE GREEN USP 2-0 EP 3, 15 X 75 CM DOUBLE NEEDLE CVY-26 CARD ATRAMAT POLYESTER SURGICAL SUTURE GREEN USP 2-0 EP 3, 15 X 75 CM DOUBLE NEEDLE CVY-26 CARDIOVASCULAR PREMIUM TAPER CUTTING 26 MM 1/2 CIRCLE KIT 6 UNITSPOLIESTER USP 2-0, 15 X 75 CM DOBLE AGUJA CVY-26 CARDIOVASCULAR AHUSADA PUNTA CORTANTE PREMIUM 26 MM 1/2 CIRCULO KIT CON 6 SOBRE
Catalog Number
CVY2652/2-75X15KM
Brand Name
ATRAMAT
Version/Model Number
POLIESTER
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
K905285,K905285
Product Code
GAS
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyester
Public Device Record Key
bc05dfbc-7696-40df-a79c-dfcd5bf51b51
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
July 27, 2018
Package DI Number
07500142180255
Quantity per Package
6
Contains DI Package
07500142080258
Package Discontinue Date
December 31, 2040
Package Status
In Commercial Distribution
Package Type
HALF A 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 |