Duns Number:040729840
Device Description: CASTROVIEJO NEEDLE HOLDER STRAIGHT WITHOUT LOCK TUNGSTEN CARBIDE DUST TIP ROUND HANLDE
Catalog Number
-
Brand Name
CASTROVIEJO NEEDLE HOLDER
Version/Model Number
2300-022
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 15, 2020
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"
Yes
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
447b83f2-0beb-4740-8539-645863fbcbff
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
May 11, 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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |