Duns Number:058614483
Device Description: Custom Suture Pack, (2) 88862589-63, (2) 88863324-56, (4) GS-832, (2) VLOCM0024, (2) VP-52 Custom Suture Pack, (2) 88862589-63, (2) 88863324-56, (4) GS-832, (2) VLOCM0024, (2) VP-521-X, (1) VP-522-X, (2) VP-557-X, (12) VP-761-X
Catalog Number
-
Brand Name
Syneture
Version/Model Number
US1697
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 02, 2019
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
4d927ebc-4d3e-4576-9033-804f82f23bee
Public Version Date
September 05, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20884521581187
Quantity per Package
6
Contains DI Package
10884521581180
Package Discontinue Date
October 02, 2019
Package Status
Not in Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |