Duns Number:058614483
Device Description: Custom Suture Pack, (2) 88862623-53, (1) 88863256-51, (2) 88863271-41, (2) 88866267-61, (1 Custom Suture Pack, (2) 88862623-53, (1) 88863256-51, (2) 88863271-41, (2) 88866267-61, (1) CL-863, (3) CS-16-M, (2) GLS-323, (1) S-193, (1) S-346, (1) Sl-5679, (1) SM-5627, (2) SM-691, (2) SS-678, (4
Catalog Number
US1693
Brand Name
Syneture
Version/Model Number
US1693
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
0a7553c3-dfba-4a46-b664-dd524f34a898
Public Version Date
October 03, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |