Duns Number:076907973
Device Description: Pediatric single Loop Leg Prep is made from 3/8” 304 grade Stainless Steel and a soft mold Pediatric single Loop Leg Prep is made from 3/8” 304 grade Stainless Steel and a soft molded pad. Used for prepping of the leg of children for surgery. Attaches to the side rail of operating table with clamp such as clark socket(sold separately) and any other clamp that accepts a 3/8" round rod. Depending on the clamp, this leg prepper can be adjusted in many different ways. Includes 1 soft molded pad. Replacements MCM156 (sold separately). .
Catalog Number
MCM158
Brand Name
NA
Version/Model Number
MCM158
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
b139bf5e-33e4-4666-9087-7c488d222dd8
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 |