Duns Number:041546137
Device Description: Castroviejo Needle Holder, Standart Jaws, Gripping Surface 11.00 mm, Curved, With Lock, Le Castroviejo Needle Holder, Standart Jaws, Gripping Surface 11.00 mm, Curved, With Lock, Length 140mm, Titanium
Catalog Number
8-100T
Brand Name
Rumex
Version/Model Number
8-100T
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
852999e3-5a85-4ef9-a4ed-5e31c1d759c6
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
June 03, 2020
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 | 834 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |