Duns Number:008018525
Device Description: Suture 1 - Needle Type CU-1, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Lengt Suture 1 - Needle Type CU-1, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12" / Suture 2 - Needle Type PC-5, Black Braided Silk(BBS), Suture Size 4-0, Suture Lenght 30"
Catalog Number
-
Brand Name
A.C.S® (Alcon Closure System), PAIR-PAK II®
Version/Model Number
8065307201
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAP
Product Code Name
Suture, Nonabsorbable, Silk
Public Device Record Key
3e4efb5f-80ae-4124-8ac7-14d6873e4e87
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
October 24, 2015
Package DI Number
10380653072010
Quantity per Package
12
Contains DI Package
00380653072013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |