Duns Number:079467378
Device Description: Kwire, 1.4mm x 460 mm Nitinol, blunt drill
Catalog Number
02-14-N460-BD
Brand Name
Omnia Medical PsiF
Version/Model Number
02-14-N460-BD
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
3e58ff05-75a0-4e72-bd23-2033e29ff7e9
Public Version Date
October 22, 2021
Public Version Number
1
DI Record Publish Date
October 14, 2021
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |
| U | Unclassified | 1 |