FDA.reportPublic FDA data

NA

Primary DI
10810030861437
Brand
NA
Company
MID CENTRAL MEDICAL CORP.
Model
AMB401
Catalog number
AMB401
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
Update
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 extension, non-poweredA non-powered, 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 or spinal surgery, C- or O-arm use). It typically consists of height, length and angle adjustable supports or telescopic bars/plates (e.g., leg spar).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0
Length0
Width0

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
10810030861772NATBL5106TBL51062020-11-16
10810030861789NATBL5107TBL51072020-11-16
10810030861796NATBL5108TBL51082020-11-16
10810030861802NATBL5109TBL51092020-11-16
10810030861819NATBL5060TBL50602020-11-16
10810030861826NATBL5061TBL50612020-11-16
10810030861833NATBL5062TBL50622020-11-16
10810030861840NATBL5063TBL50632020-11-16
10810030861857NATBL5064TBL50642020-11-16
10810030861864NATBL5065TBL50652020-11-16
10810030861871NATBL5066TBL50662020-11-16
10810030861680NATBL5006TBL50062020-10-31
10810030861697NATBL5007TBL50072020-10-31
10810030861703NATBL5008TBL50082020-10-31
10810030861710NATBL5009TBL50092020-10-31
10810030861727NATBL5101TBL51012020-10-31
10810030861734NATBL5102TBL51022020-10-31
10810030861741NATBL5103TBL51032020-10-31
10810030861758NATBL5104TBL51042020-10-31
10810030861765NATBL5105TBL51052020-10-31

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Primary DI, Brand, Company table
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