Duns Number:040729840
Device Description: JACOBSON NEEDLE HOLDER WITH STREAMLINED BOX LOCK TUNGSTEN CARBIDE DUST TIP TITANIUM MIDDLE JACOBSON NEEDLE HOLDER WITH STREAMLINED BOX LOCK TUNGSTEN CARBIDE DUST TIP TITANIUM MIDDLE WEIGHT
Catalog Number
2600-713
Brand Name
JACOBSON NEEDLE HOLDER
Version/Model Number
2600-713
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
dca72957-03de-4276-8127-21d71f32de74
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
September 21, 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 |