Duns Number:023904428
Device Description: SMALL BONE OSCILLATING BLADE 30.0 mm x 9.0 mm x 0.38 mm
Catalog Number
-
Brand Name
McKesson
Version/Model Number
174-OSS-3225
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"
Yes
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
K102743,K102743
Product Code
GFA
Product Code Name
Blade, Saw, General & Plastic Surgery, Surgical
Public Device Record Key
b1cccbfb-b26a-438e-9037-e6ba339d61e4
Public Version Date
January 22, 2021
Public Version Number
2
DI Record Publish Date
April 27, 2020
Package DI Number
20612479225163
Quantity per Package
5
Contains DI Package
10612479225159
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |