Duns Number:076907973
Device Description: Carpal Arm and Hand Surgery Table w/ 2" Pad. This rectangle shaped arm/hand table offers s Carpal Arm and Hand Surgery Table w/ 2" Pad. This rectangle shaped arm/hand table offers superior rigidity without the obstruction of a lower leg. Radiolucent center portion allows c-arm access. Clamps securely to the OR table rail with our integral posi-lock clamps. No extra clamps needed or to get misplaced. Full size 18" x 32" operating surface and plenty of lower support. This is the ultimate choice for carpal tunnel procedures and many others. Even though there is no lower leg, the support under this table is superior! 2" pad included..
Catalog Number
MCM330
Brand Name
NA
Version/Model Number
MCM330
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"
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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
HRK
Product Code Name
Table, Instrument, Manual, Ophthalmic
Public Device Record Key
10b090cd-806a-49ed-a15c-4b21b901960f
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 15, 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 |