FDA.report

NA

Primary DI
10810030861376
Brand
NA
Company
MID CENTRAL MEDICAL CORP.
Model
MCM350
Catalog number
MCM350
Device description
Equalizing Device is used when three or more digits are put in Traction. Constructed of durable composite plastic for ease of cleaning and ultimate strength. This device can be used with an IV Pole or other extremity systems. Includes cables for holding finger traps.
Published
2020-09-30
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
FOXStand, Infusion

Product Code Classifications

CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810030861376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081003086137610810030861376

GMDN Terms

TermDefinition
Surgical traction tensioner connectorA connecting/extension device intended to be fastened between a surgical traction tensioner/rod/cord and a patient-contact traction device (e.g., orthopaedic bone wire, foot boot, hand wrap/trap) for the application of adjustable pulling force (traction) to a body part (e.g., leg, arm, hand, head, pelvis). It is intended to be used during a surgical procedure (e.g., fracture reduction, pelvic reconstruction); some types may in addition be used in an orthopaedic bed over a period typically to promote reduction/healing of a fracture. This is a reusable device.

Device Sizes

TypeValueUnit
Height4Inch
Length9Inch
Width2Inch

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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10810030863301NAMCM322-4MCM322-42021-09-20
10810030863318NAMCM414MCM4142021-09-20
10810030863325NAMCM408MCM4082021-09-20

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