Duns Number:076907973
Device Description: Underpad Mount Phenolic Hourglass Surgery Table W/Double Leg and 2" Pad. As Ambulatory Sur Underpad Mount Phenolic Hourglass Surgery Table W/Double Leg and 2" Pad. As Ambulatory Surgery Centers become more common in the medical field, many surgeons wish to perform Arm/hand surgery on a Stretcher or Stretcher Chair. We have an extended range of Arm/Hand tables that slide under the pad of these units and are held in place by the weight of the patient. This hourglass shaped arm/hand table is constructed of durable phenolic like the surface of the OR table. The hourglass shape extends to 24" width to provide wrist support for the surgeon. It slides easily under the pad and is held in place by the patients weight. Radiolucent center portion allows c-arm access. 15" x 32" operating surface and plenty of lower support. Leg adjusts up to 12" to meet the ideal height for the surgeon. Double lower leg portion for added stability. 2" pad included..
Catalog Number
MCM338
Brand Name
NA
Version/Model Number
MCM338
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
HRK
Product Code Name
Table, Instrument, Manual, Ophthalmic
Public Device Record Key
be445010-0c60-4003-a29c-beed87ccd7b8
Public Version Date
June 10, 2022
Public Version Number
2
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 |