Duns Number:053146767
Device Description: The RB 001 Multi-Purpose rail-mounted slide bracket allows for a variety of mounting optio The RB 001 Multi-Purpose rail-mounted slide bracket allows for a variety of mounting options. For use on Fairfield-style rails only, with equipment that requires a 1-1/8" x 3/16" mounting slot.
Catalog Number
RB 001
Brand Name
RB 001 Rail-Mounted Slide Bracket
Version/Model Number
RB 001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZO
Product Code Name
Set, Tubing And Support, Ventilator (W Harness)
Public Device Record Key
2204492a-dc44-4a1a-b82c-1f515e48d0a3
Public Version Date
May 19, 2021
Public Version Number
2
DI Record Publish Date
February 28, 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 | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |