FDA.report

NA

Primary DI
10810030860461
Brand
NA
Company
MID CENTRAL MEDICAL CORP.
Model
MCM612
Catalog number
MCM612
Device description
TKR Foot Rest (radiolucent). Assists in supporting legs for total knee replacement procedures. Constructed of stainless steel and polyoxy-methylene for ultimate support. Top portion is radiolucent. 5/8" diameter stainless steel post fits into Clark Socket (sold separately). Includes one single use disposable pad of soft black cushion. Replacement pads available for purchase separately. .
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications

CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810030860461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081003086046110810030860461

GMDN Terms

TermDefinition
Leg procedure positionerA preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure). It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. This is a reusable device.

Device Sizes

TypeValueUnit
Depth2Inch
Height16.5Inch
Length12Inch

Sterilization Methods

Method

Contacts

PhoneEmail
701-825-6100office@midcentralmedical.com

Regulatory Flags

DUNS number
076907973
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00810030863458NAMCM556-DRAPEMCM556-DRAPE2023-03-01
10810030860904NAMCM271-6MCM271-62022-04-01
10810030863332NAMCM519-HMCM519-H2022-04-01
10810030863349NAMCM551-HMCM551-H2022-04-01
10810030863356NAMCM303634HBCAMCM303634HBCA2022-04-01
10810030863363NAMCM304834HBCAMCM304834HBCA2022-04-01
10810030863370NAMCM306034HBCAMCM306034HBCA2022-04-01
10810030863387NAMCM307234HBCAMCM307234HBCA2022-04-01
10810030863394NAMCM705MCM7052022-04-01
10810030863400NAMCM706MCM7062022-04-01
10810030863417NAMCM710MCM7102022-04-01
10810030863424NAMCM711MCM7112022-04-01
10810030863271NAMCM312-3MCM312-32021-09-20
10810030863288NAMCM312-4MCM312-42021-09-20
10810030863295NAMCM322-3MCM322-32021-09-20
10810030863301NAMCM322-4MCM322-42021-09-20
10810030863318NAMCM414MCM4142021-09-20
10810030863325NAMCM408MCM4082021-09-20

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