Duns Number:040729840
Device Description: NAUGHTEN-MORGAN NEEDLE HOLDER DOUBLE ARTICULATING STRAIGHT DEBAKEY TUNGSTEN CARBIDE DUST T
Catalog Number
2601-350
Brand Name
NAUGHTEN-MORGAN NEEDLE HOLDER
Version/Model Number
2601-350
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
FHQ
Product Code Name
HOLDER, NEEDLE, GASTROENTEROLOGIC
Public Device Record Key
9ea37b8a-332b-46b3-8ff9-b2164bcd94c8
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
September 12, 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 | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |