Duns Number:076907973
Device Description: Elbow arthroscopy positioner with pad. This surgical arm prepper places the patients elbow Elbow arthroscopy positioner with pad. This surgical arm prepper places the patients elbow in optimal positioning for elbow arthroscopy. Easy access to a tourniquet with out interfering with the sterile field. Prevents slipping with out the use of straps. Durable Stainless steel construction. Includes pressure diffusion pad to reduce impact on nerves and tissue..
Catalog Number
MCM450
Brand Name
NA
Version/Model Number
MCM450
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
NOD
Product Code Name
Board, Arm (With Cover), Non-Sterile
Public Device Record Key
e45fa904-8dde-4f58-9c3b-c7d4cf0290c7
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 30, 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 |