Duns Number:109903521
Device Description: ULTRABRAID II, No.2 BLUE SUTURE 38 DEGREE BOX OF 10
Catalog Number
72202965
Brand Name
ULTRABRAID
Version/Model Number
72202965
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K101377,K101377
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
6e018daf-251e-4c9a-b8d0-a69416c541fc
Public Version Date
February 05, 2021
Public Version Number
7
DI Record Publish Date
August 29, 2015
Package DI Number
20885554017650
Quantity per Package
10
Contains DI Package
00885554017656
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |