Duns Number:076907973
Device Description: The Insta-Rail quickly and easily attaches to your imaging table or other surface making i The Insta-Rail quickly and easily attaches to your imaging table or other surface making it more versatile for your accessory needs. Features a clamp opening of 1 1/2". So it is designed to be compatible with all types of imaging tables. Stainless steel rail is 6" long x 1 1/8" high x 3/8" thick. It is the same type of rail used on all US made O.R. tables..
Catalog Number
MCM168
Brand Name
NA
Version/Model Number
MCM168
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
FWZ
Product Code Name
Operating Room Accessories Table Tray
Public Device Record Key
8af633d3-cf6f-4fbc-98de-edee0ca3ce4b
Public Version Date
September 09, 2020
Public Version Number
1
DI Record Publish Date
September 01, 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 | 342 |