Duns Number:058614483
Device Description: Custom Suture Pack, (2) CL924, (2) CS9M, (1) S183, (1) S317, (2) SM5627, (1) SS678, (1) UL Custom Suture Pack, (2) CL924, (2) CS9M, (1) S183, (1) S317, (2) SM5627, (1) SS678, (1) UL215, (1) VP557MX, (2) VP558X, (2) VP706X, (1) VP713MX
Catalog Number
US1750
Brand Name
Syneture
Version/Model Number
US1750
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
d50281ef-ded8-462a-bfa7-b94e762ce62a
Public Version Date
March 12, 2020
Public Version Number
2
DI Record Publish Date
December 11, 2019
Package DI Number
20884521794563
Quantity per Package
6
Contains DI Package
10884521794566
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 |