Duns Number:058614483
Device Description: (1) CL-830, (1) CL-904, (3) CL-905, (2) CN-792
Catalog Number
US1602
Brand Name
Syneture
Version/Model Number
US1602
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
8c3a458f-79b5-4cf7-954c-d0efc642a62f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 17, 2018
Package DI Number
10884521725515
Quantity per Package
6
Contains DI Package
20884521725512
Package Discontinue Date
-
Package Status
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 |