Duns Number:315018218
Device Description: ARTHCUT Punch, 45 °, angled left, standard, 5,5 x 2,4 mm, consisting of: FO725R, FO728R, F ARTHCUT Punch, 45 °, angled left, standard, 5,5 x 2,4 mm, consisting of: FO725R, FO728R, FO797R, classic art, non-sterile, reusable
Catalog Number
FO677R
Brand Name
ARTHCUT
Version/Model Number
FO677R
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
-
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
HRX
Product Code Name
Arthroscope
Public Device Record Key
d9cf75c0-530c-4b61-b1d0-25393858a755
Public Version Date
September 14, 2022
Public Version Number
2
DI Record Publish Date
May 20, 2020
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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |