Duns Number:832696038
Device Description: PERIOSTEAL ELEVATOR STRONG CURVE, PHENOLIC HANDLE STRAIGHT EDGE, BLADE 13MM OVERALL LENGTH PERIOSTEAL ELEVATOR STRONG CURVE, PHENOLIC HANDLE STRAIGHT EDGE, BLADE 13MM OVERALL LENGTH 7-1/2" (19CM)
Catalog Number
OS1090-008
Brand Name
V. Mueller
Version/Model Number
OS1090-008
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
GEG
Product Code Name
ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
d366ae4d-4a01-40e1-9a2e-2739625bb3a5
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
September 10, 2018
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 | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |