Duns Number:315304071
Device Description: NEEDLE HOLDER INSERT WITH SHEATH Ø 3.5MM straight with carbide insert, WL 310mm, with irr NEEDLE HOLDER INSERT WITH SHEATH Ø 3.5MM straight with carbide insert, WL 310mm, with irrigation connection, reusable
Catalog Number
8391.504
Brand Name
NA
Version/Model Number
8391504
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
FHQ
Product Code Name
HOLDER, NEEDLE, GASTROENTEROLOGIC
Public Device Record Key
19f8c525-e1da-4800-b64e-14f900a3cff9
Public Version Date
October 27, 2022
Public Version Number
9
DI Record Publish Date
September 28, 2016
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |