Duns Number:071595540
Device Description: Oscillator Blade, Coated, 14/8 x 75 x 1.37mm
Catalog Number
5071-265
Brand Name
NA
Version/Model Number
5071-265
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 09, 2022
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
GFA
Product Code Name
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Public Device Record Key
156298a4-9ac4-440f-8e97-b93328e8d90a
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
April 20, 2017
Package DI Number
30845854045941
Quantity per Package
5
Contains DI Package
20845854045944
Package Discontinue Date
June 09, 2022
Package Status
Not 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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |