Duns Number:618214410
Device Description: Joseph Elevator 7" (17.5cm), blade 4mm wide, slight curve
Catalog Number
210-066
Brand Name
Hayden Medical
Version/Model Number
210-066
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
ef1cf1e8-9455-4731-bbb6-ba3c3ab8bade
Public Version Date
August 04, 2022
Public Version Number
1
DI Record Publish Date
July 27, 2022
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 | 2893 |
2 | A medical device with a moderate to high risk that requires special controls. | 195 |