Duns Number:556115970
Device Description: SUTURE,PDO,2-0,NCT-1
Catalog Number
-
Brand Name
Oasis
Version/Model Number
MV-Z339
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K073614,K073614,K073614
Product Code
NEW
Product Code Name
Suture, Surgical, Absorbable, Polydioxanone
Public Device Record Key
73e5ac0f-b165-40c2-8aa0-509c43bf26c7
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
January 14, 2016
Package DI Number
B031MVZ3391
Quantity per Package
12
Contains DI Package
B031MVZ3390
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 62 |