Duns Number:058614483
Device Description: Custom Suture Pack, (1) L405, (1) CL803, (2) CL802, (3) VP832X, (1) VP935X, (1) SM693, (3) Custom Suture Pack, (1) L405, (1) CL803, (2) CL802, (3) VP832X, (1) VP935X, (1) SM693, (3) SN775
Catalog Number
US1757
Brand Name
Syneture
Version/Model Number
US1757
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
-
Product Code
OVN
Product Code Name
Suture kit
Public Device Record Key
4b17fc64-dd50-4da9-b733-2d5bfb96fb26
Public Version Date
January 17, 2020
Public Version Number
1
DI Record Publish Date
January 09, 2020
Package DI Number
20884521806136
Quantity per Package
5
Contains DI Package
10884521806139
Package Discontinue Date
-
Package Status
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 |