Duns Number:058614483
Device Description: Custom Suture Pack, (6) CN-290, (2) GMM-344L, (8) GS-833, (1) S-193, (2) S-305, (5) VP-521 Custom Suture Pack, (6) CN-290, (2) GMM-344L, (8) GS-833, (1) S-193, (2) S-305, (5) VP-521-X, (1) VP-76-X, (2) CL-842, (6) CL-903, (5) VP-521-X, (6) VP-522-X, (4) VP-581-X
Catalog Number
-
Brand Name
Syneture
Version/Model Number
US1702
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 02, 2021
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
OVN
Product Code Name
Suture kit
Public Device Record Key
7f56078b-e6bb-4fdf-adf3-2611c5386927
Public Version Date
September 08, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20884521548371
Quantity per Package
2
Contains DI Package
30884521548378
Package Discontinue Date
March 31, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |