FDA.reportPublic FDA data

NA

Primary DI
10810030861574
Brand
NA
Company
MID CENTRAL MEDICAL CORP.
Model
AMB450
Catalog number
AMB450
Device description
Elbow arthroscopy positioner with pad. This surgical arm prepper places the patients elbow in optimal positioning for elbow arthroscopy. Easy access to a tourniquet with out interfering with the sterile field. Prevents slipping with out the use of straps. Durable Stainless steel construction. Includes pressure diffusion pad to reduce impact on nerves and tissue. .
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
10810030861574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081003086157410810030861574

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.

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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