FDA.reportPublic FDA data

Arm restraint cuff

Primary DI
04046768027152
Brand
Arm restraint cuff
Company
MAQUET GmbH
Model
10014600
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BWNTABLE AND ATTACHMENTS, OPERATING-ROOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWNTable And Attachments, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046768027152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046768027152040467680271524046768027152

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315435859
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053275000011GETINGE6710GSS67N Model 67102019-02-06
04053275000028GETINGE 6713GSS67N Model 67132019-02-06
04053275000035GETINGE6717GSS67N Model 67172019-02-06
04046768146600Traction Adapter100372AC2025-11-30
04046768151468Connection Bracket100405A02025-11-30
04046768151475Connection Bracket100405F02025-11-30
04046768151567Traction bar with ball for 1160 and 7700100740B02025-11-30
04046768151574Traction bar for 1160 and 7700100741B02025-11-30
04046768112704Disposable cover100729A02025-06-17
04046768148321Retrofit kit head fixation I116036A02024-11-21
04046768151208Retrofit kit head fixation II116036B02024-11-21
04046768000094Connection bracket100208002022-09-22
04046768000124Connector100258002022-09-22
04046768000421Cross-bar attachment100523002022-09-22
04046768000452Support arm100558002022-09-22
04046768001510Head rest adapter100207A02022-09-22
04046768001657Fixture100265A02022-09-22
04046768001688Horseshoe head rest100272A02022-09-22
04046768001695Flat head rest100273A02022-09-22
04046768001701Motorised head rest adjustment100274A02022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995232030NASTERIS CORPORATIONBWN2026-05-26
10381780542254MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONBWN2026-02-05
10381780542261MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONBWN2026-02-05
03701602300044ARCH - Boot SInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300051ARCH - Boot MInnovative Orthopedic Technologies AGBWN2026-01-13
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03701602300075ARCH - Boot SInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300099Velcro Strap longInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300105PURIST - Leg positioning systemInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300112PURIST / OLH - Boot S - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300129PURIST / OLH - Boot M - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300136OLH #ERDP - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300143OLH #ERD - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300150OLH #ER - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300167OLH #BHA- BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300174OLH #ED - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300181OLH - DENYER PLUS - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300198OLH - DENYER - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300204OLH - US/EU - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300211POP UNIVERSALInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300228OLH #ERDPInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300235OLH #ERDInnovative Orthopedic Technologies AGBWN2026-01-13
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03701602300259MP XRAYCERInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300266DAA TOP 360Innovative Orthopedic Technologies AGBWN2026-01-13
03701602300273OLH #BHAInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300280OLH #BHSInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300297OLH #EDInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300303OLH - DENYER PLUSInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300310OLH - DENYERInnovative Orthopedic Technologies AGBWN2026-01-13