Duns Number:317409001
Device Description: Oscillating Saw Blade - for Linvatec® Hall® 100x25x1.27mm
Catalog Number
05.003.639S
Brand Name
Oscillating Saw Blade
Version/Model Number
05.003.639S
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)
-
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
50176e4d-ded7-4535-a68e-474cf6ece9ee
Public Version Date
May 28, 2021
Public Version Number
1
DI Record Publish Date
May 20, 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 | 154 |
2 | A medical device with a moderate to high risk that requires special controls. | 70 |