Duns Number:131747628
Device Description: 3mm Suture Tak ShaverDrill
Catalog Number
AR-1250LTSR
Brand Name
Arthrex®
Version/Model Number
AR-1250LTSR
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
HWE
Product Code Name
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Public Device Record Key
6816d0a1-ad76-4fe6-b26c-3eba50fe7460
Public Version Date
July 04, 2022
Public Version Number
8
DI Record Publish Date
February 15, 2017
Package DI Number
10888867239439
Quantity per Package
5
Contains DI Package
00888867239432
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 |