Duns Number:989365556
Device Description: GLOBAL STEPTECH ANCHOR PEG GLENOID STEPTECH OSCL RASP LG +5 LINV FITS: CONMED MICROFREE AN GLOBAL STEPTECH ANCHOR PEG GLENOID STEPTECH OSCL RASP LG +5 LINV FITS: CONMED MICROFREE AND HALL MICROPOWER LARGE +5MM
Catalog Number
223000364
Brand Name
GLOBAL STEPTECH
Version/Model Number
223000364
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KIJ
Product Code Name
Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment
Public Device Record Key
4c063858-d463-41bb-90b8-22092b815b60
Public Version Date
February 22, 2021
Public Version Number
1
DI Record Publish Date
February 14, 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 | 3549 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2188 |
| 3 | A medical device with high risk that requires premarket approval | 418 |