Duns Number:131747628
Device Description: 600 SAGITTAL SAWBLD 90X 25.4X 1.27 MM
Catalog Number
AR-600-105S
Brand Name
Arthrex®
Version/Model Number
AR-600-105S
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
fd76a0df-a616-4849-a95b-9d1fc9ad5fa6
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
September 15, 2018
Package DI Number
10888867110615
Quantity per Package
5
Contains DI Package
00888867110618
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 | 6506 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3411 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 2 |