Duns Number:027680821
Device Description: Single use device intended to cover exposed ends of orthopedic pin and k-wires to help pro
Catalog Number
-
Brand Name
Oxboro™ Pin Cover
Version/Model Number
101001BBG
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 15, 2021
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)
-
Over the Counter (OTC)
-
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
6c87fcb6-ad2e-4f97-b948-d880ee774910
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
June 07, 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 | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |