Duns Number:076907973
Device Description: Candy Cane Stirrup (1 only) designed to hold patients lower limbs during lithotomy cases. Candy Cane Stirrup (1 only) designed to hold patients lower limbs during lithotomy cases. Constructed from 304 stainless steel for durability and longevity. Integral clamp allows height adjustment for 23"–41". Large 8" arc allows for additional leg clearance. Mounts to OR table rail with clark socket (MCM160 sold separately). 1" wide cotton strap that conforms to 9" loops is included. 60 lb. capacity. Mounts with standard clark socket(sold separately).
Catalog Number
MCM150
Brand Name
NA
Version/Model Number
MCM150
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
5b34f1c4-5cc7-44e7-87bd-a540925be54c
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 |