FDA.reportPublic FDA data

NA

Primary DI
10810030861437
Brand
NA
Company
MID CENTRAL MEDICAL CORP.
Model
MCM401
Catalog number
MCM401
Device description
Radiolucent Height Adjustable Armboard with Posi-Lock. This armboard is designed to support patient’s arms during surgery. Large portion of board is also radiolucent for C-arm capabilities. Rotates 180 degrees to desired position. It also adjusts in height to match the top of the OR table or to elevate the patients arm if needed. Adjusts up to 4 in height. Standard size is 6" x 26". Clamps securely to any American made OR table rail. Uses 26" L armboard pad sold separately. .
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NODBoard, Arm (With Cover), Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NODBoard, Arm (With Cover), Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810030861437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081003086143710810030861437

GMDN Terms#

Term, Definition table
TermDefinition
Operating table orthopaedic extensionAn orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table or table top to provide additional support to a patient's body segment or part during orthopaedic surgical procedures (e.g., lower trunk for traction of the legs, upper body during shoulder surgery). It typically consists of height, length and angle adjustable supports or telescopic bars/plates.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.375Inch
Length26Inch
Width6Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810030863434NAMCM554-DRAPEMCM554-DRAPE2023-03-01
00810030863441NAMCM555-DRAPEMCM555-DRAPE2023-03-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06943718240037DemaxBeijing Demax Medical Technology Co., Ltd.NOD2025-01-09
06943718240044DemaxBeijing Demax Medical Technology Co., Ltd.NOD2025-01-09
06943718240051DemaxBeijing Demax Medical Technology Co., Ltd.NOD2025-01-09
06943718240068DemaxBeijing Demax Medical Technology Co., Ltd.NOD2025-01-09
00810082221534Soule MedicalSOULE CO., THENOD2023-07-06
10766923025212Pedi BoardPEDICRAFT, INC.NOD2023-06-07
10766923025229Pedi BoardPEDICRAFT, INC.NOD2023-06-07
10766923025236Pedi BoardPEDICRAFT, INC.NOD2023-06-07
10766923025243Pedi BoardPEDICRAFT, INC.NOD2023-06-07
10766923025250Pedi BoardPEDICRAFT, INC.NOD2023-06-07
10766923025267Pedi BoardPEDICRAFT, INC.NOD2023-06-07
10766923025304Pedi BoardPEDICRAFT, INC.NOD2023-06-07
10840118405246MTIMedical Technology Industries, Inc.NOD2023-04-28
10840118429303MTIMedical Technology Industries, Inc.NOD2023-04-28
06943718240013DemaxBeijing Demax Medical Technology Co., Ltd.NOD2023-02-13
06943718240020DemaxBeijing Demax Medical Technology Co., Ltd.NOD2023-02-13
06943718244103DemaxBeijing Demax Medical Technology Co., Ltd.NOD2023-02-13
00733657244786ACS DISPOSABLE 30/CSALIMED, INC.NOD2022-12-01
00733657244793ACS W/ STRAP (12/CS)ALIMED, INC.NOD2022-12-01
00840216112278PERFORMANCE HEALTHASP GLOBAL, LLCNOD2022-05-24
00840216112285PERFORMANCE HEALTHASP GLOBAL, LLCNOD2022-05-24
00840216112292PERFORMANCE HEALTHASP GLOBAL, LLCNOD2022-05-24
00840216112308PERFORMANCE HEALTHASP GLOBAL, LLCNOD2022-05-24
00840216112315PERFORMANCE HEALTHASP GLOBAL, LLCNOD2022-05-24
00653405001730NAConmed CorporationNOD2021-10-06
10810030863318NAMID CENTRAL MEDICAL CORP.NOD2021-09-20
10810030863325NAMID CENTRAL MEDICAL CORP.NOD2021-09-20
10810030861444NAMID CENTRAL MEDICAL CORP.NOD2020-09-30
10810030861451NAMID CENTRAL MEDICAL CORP.NOD2020-09-30
10810030861468NAMID CENTRAL MEDICAL CORP.NOD2020-09-30