Duns Number:109903521
Device Description: MODIFIED C2 GLEN REAMER SM F/USE W/ANGLE DRIVER
Catalog Number
71928984
Brand Name
COFIELD
Version/Model Number
71928984
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 09, 2017
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
K121714
Product Code
HSD
Product Code Name
PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Public Device Record Key
ccf2c6b8-ae99-4cdb-b79c-9b119385f4ae
Public Version Date
October 11, 2021
Public Version Number
4
DI Record Publish Date
August 29, 2015
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |