Duns Number:058614483
Device Description: Custom Suture Pack, (1) VP557MX, (1) VP733MX, (1) VP735MX, (6) 8886325151, (1) S195, (1) S Custom Suture Pack, (1) VP557MX, (1) VP733MX, (1) VP735MX, (6) 8886325151, (1) S195, (1) S317, (1) S193, (1) CL975, (3) 8886867901, (2) GS62M, (1) GLS322, (1) CL953, (1) CL843, (2) SM5637, (1) VS870
Catalog Number
US1754
Brand Name
Syneture
Version/Model Number
US1754
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
c9738d2b-5d64-4e2d-83af-974171ea9fc1
Public Version Date
January 15, 2020
Public Version Number
1
DI Record Publish Date
January 07, 2020
Package DI Number
20884521795478
Quantity per Package
6
Contains DI Package
10884521795471
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 |