Duns Number:783328149
Device Description: MATHIEU N/H 5.5" W/HOOK
Catalog Number
-
Brand Name
J & J INSTRUMENTS
Version/Model Number
25-7670
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HXK
Product Code Name
Holder, Needle; Orthopedic
Public Device Record Key
d06f49c4-ec69-4f22-8459-dd8bac42a060
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
November 05, 2019
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 | 840 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |