Duns Number:109903521
Device Description: ULTRABRAID 2-0 WHITE SUTURE AND NEEDLES, 24 INCHES. 10 ULTRABRAID 2-0 WHITE SUTURE AND NEEDLES, 24 INCHES. 10 PACK
Catalog Number
72204327
Brand Name
Ultrabraid
Version/Model Number
72204327
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
K041216,K041216
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
1b637bf0-8bcf-4020-8700-daae87619849
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
April 12, 2016
Package DI Number
20885554034848
Quantity per Package
10
Contains DI Package
00885554034844
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 |