Duns Number:186127825
Device Description: OSSEOGUARD® PTFE SUTURE USP 3-0 16MM 3/8 CIRCLE PRECISION REVERSE CUTTING
Catalog Number
-
Brand Name
OSSEOGUARD®
Version/Model Number
OS3016
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
NBY
Product Code Name
SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE
Public Device Record Key
a1a8978e-bd00-4eea-99bd-377791483b6c
Public Version Date
March 10, 2022
Public Version Number
3
DI Record Publish Date
January 31, 2019
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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1962 |