Duns Number:023055619
Device Description: Castroviejo Micro Needle Holder, Round Handle, Curved, Streamline Diamond Dust™ jaw, 6" / Castroviejo Micro Needle Holder, Round Handle, Curved, Streamline Diamond Dust™ jaw, 6" / 15 cm
Catalog Number
3003-94A
Brand Name
SCANLAN® Needle Holder
Version/Model Number
3003-94A
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
8166108b-38f5-4c4d-9e35-e51d30f748ba
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
December 05, 2019
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 | 1949 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 855 |