FDA.reportPublic FDA data

SINGLE ARM TRAPEZE ASSEMBLY

Primary DI
00850520008006
Brand
SINGLE ARM TRAPEZE ASSEMBLY
Company
KREG MEDICAL INC.
Model
ASM100105
Device description
Single Arm Trapeze
Published
2018-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILZAccessories, Traction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILZAccessories, TractionPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850520008006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850520008006008505200080068505200080060850520008006

GMDN Terms#

Term, Definition table
TermDefinition
Bed traction frameAn adjustable support structure usually attached to a patient's bed and designed for management of various orthopaedic conditions. It typically consists of a steel tubing structure that includes brackets and/or pulleys; it includes a post for the headboard and/or footboard, and often an adjustable-length top bar or rail with a hanging trapeze. The device is designed for use in combination with weights and/or other attachments to produce the desired traction in patients while permitting some freedom of motion. It is used to treat patients with fractures and other orthopaedic disorders (e.g., of the lower or cervical spine, hip).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 760-5734kmiudiInfo@kreg.us

Regulatory Flags#

DUNS number
079220324
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850520008280AP MAX MATTRESS SYSTEMASM2001042023-10-16
00850520008013OXYGEN TANK HOLDERASM1002172020-06-12
00850520008099EZ WIDER, FOOT WIDTH EXTENSION - RHASM2001142020-06-12
00850520008112EZ WIDER, FOOT WIDTH EXTENSION - LHASM2001152020-06-12
00850520008129EZ WIDER, FOOT LENGTH EXTENSIONASM1001062020-06-12
00850520008020CATALYST BARIATRIC BEDASM1001122018-09-21
00850520008037THE KREG INTEGRATED CLRT MATTRESS SYSTEMASM2001002018-09-21
00850520008044STAGE IV, LOW AIR LOSS, L/PASM2001112018-09-21
00850520008051EZ WIDER BARIATRIC BEDASM1001292018-09-21
00850520008068EZ WIDER BARIATRIC BEDASM1001002018-09-21
00850520008075EZ WIDER BARIATRIC BEDASM1001302018-09-21
00850520008082EZ WIDER BARIATRIC BEDASM1001042018-09-21
00850520008143CATALYST NON-EXPANDABLE BEDASM1001132018-09-21
00850520008150THE KREG INTEGRATED CLRT MATTRESS SYSTEMASM1002022018-09-21
00850520008167THE KREG INTEGRATED ALTERNATING MATTRESS SYSTEMASM1002032018-09-21
00850520008174VISCO MEMORY FOAM MATTRESS ASSEMBLYASM1001162018-09-21
00850520008181COMPOSURE MATTRESS ASSEMBLYASM1002042018-09-21
00850520008198KREG AIR, STAGE IV, LOW AIR LOSS, L/P, EZ WIDERASM1001032018-09-21
00850520008204COVERLET WITH ZIPPERASM1001172018-09-21
00850520008211COVERLET WITH ZIPPERASM1001182018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888912296533CHATTANOOGADJO, LLCILZ2024-08-20
00630094171470Bioseal Inc.BIOSEALILZ2023-09-18
10630094171477Bioseal Inc.BIOSEALILZ2023-09-18
00630094163604Bioseal Inc.BIOSEALILZ2023-09-13
00630094163635Bioseal Inc.BIOSEALILZ2023-09-13
00630094163642Bioseal Inc.BIOSEALILZ2023-09-13
00630094163659Bioseal Inc.BIOSEALILZ2023-09-13
00630094163666Bioseal Inc.BIOSEALILZ2023-09-13
00630094163727Bioseal Inc.BIOSEALILZ2023-09-13
10630094163601Bioseal Inc.BIOSEALILZ2023-09-13
10630094163632Bioseal Inc.BIOSEALILZ2023-09-13
10630094163649Bioseal Inc.BIOSEALILZ2023-09-13
10630094163656Bioseal Inc.BIOSEALILZ2023-09-13
10630094163663Bioseal Inc.BIOSEALILZ2023-09-13
10630094163724Bioseal Inc.BIOSEALILZ2023-09-13
04260676050082RolkoRolko Kohlgrüber GmbHILZ2023-09-05
04260676050099RolkoRolko Kohlgrüber GmbHILZ2023-09-05
04719871180372EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180389EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180396EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180402EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
00888912268806CHATTANOOGADJO, LLCILZ2023-04-18
00888912268851CHATTANOOGADJO, LLCILZ2023-04-18
00888912258746CHATTANOOGADJO, LLCILZ2022-12-01
00749756022088DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022101DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022118DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022132DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022255DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756097253DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29