Duns Number:058614483
Device Description: Custom Suture Pack, (4) 888629114-51, (1) 88868619-03, (1) 88868677-01, (2) CL-953, (1 CL- Custom Suture Pack, (4) 888629114-51, (1) 88868619-03, (1) 88868677-01, (2) CL-953, (1 CL-954, (1) CL-975, (2) CS-17-M, (1) GS-834, (1) S-405, (3) S-608, (1) SL-5678, (1) VP-710X, (2) VP-704-MX, (1) VP-710-MX, (1) VP-737-MX
Catalog Number
-
Brand Name
Syneture
Version/Model Number
US1600
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
94c0d6da-ed12-4600-9398-5687cf257fc7
Public Version Date
April 06, 2021
Public Version Number
3
DI Record Publish Date
January 06, 2017
Package DI Number
20884521581460
Quantity per Package
6
Contains DI Package
10884521581463
Package Discontinue Date
April 02, 2021
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 |