Duns Number:108999095
Device Description: Babinski Hammer, Adjustable,
Catalog Number
3698BK
Brand Name
ADC®
Version/Model Number
3698BK
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GWZ
Product Code Name
Percussor
Public Device Record Key
10e961c4-6f49-458b-b683-9b0c322fcacb
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
00634782572501
Quantity per Package
5
Contains DI Package
00634782872502
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2395 |
2 | A medical device with a moderate to high risk that requires special controls. | 1769 |