Duns Number:621830582
Device Description: Large Ratchet, Short T Handle, 1/4" Square Internal Adapter, Ø.180 Cannulation.Black Silic Large Ratchet, Short T Handle, 1/4" Square Internal Adapter, Ø.180 Cannulation.Black Silicone , Color code "A"Sold as OEM
Catalog Number
RIV-33-11-02A
Brand Name
Bradshaw Medical Inc.
Version/Model Number
RIV-33-11-02A
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
HXX
Product Code Name
Screwdriver
Public Device Record Key
56bf23f4-b50d-4460-96bc-e9a52149a95e
Public Version Date
June 03, 2020
Public Version Number
1
DI Record Publish Date
May 26, 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 | 142 |