FDA.reportPublic FDA data

A-Box®

Primary DI
M711BTA500
Brand
A-Box®
Company
INNO Holdings, Inc.
Model
BTA-50
Device description
Radel, Tecapro
Published
2022-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711BTA500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
801-261-2236info@innovasis.com

Regulatory Flags#

DUNS number
141620464
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M711BTA2020Vector™ Pedicle Screw SystemBTA-2022026-06-05
M711LS7490Vector™ Pedicle Screw SystemLS-7492026-06-05
M711511410070Endeavor™ Stand-Alone Cervical51-1410072026-05-31
M711511410120Endeavor™ Stand-Alone Cervical51-1410122026-05-31
M711511411070Endeavor™ Stand-Alone Cervical51-1411072026-05-31
M711511411120Endeavor™ Stand-Alone Cervical51-1411122026-05-31
M711511412070Endeavor™ Stand-Alone Cervical51-1412072026-05-31
M711511412120Endeavor™ Stand-Alone Cervical51-1412122026-05-31
M711511606070Endeavor™ Stand-Alone Cervical51-1606072026-05-31
M711511607070Endeavor™ Stand-Alone Cervical51-1607072026-05-31
M711511607120Endeavor™ Stand-Alone Cervical51-1607122026-05-31
M711511608070Endeavor™ Stand-Alone Cervical51-1608072026-05-31
M711511608120Endeavor™ Stand-Alone Cervical51-1608122026-05-31
M711511609070Endeavor™ Stand-Alone Cervical51-1609072026-05-31
M711511609120Endeavor™ Stand-Alone Cervical51-1609122026-05-31
M711511610070Endeavor™ Stand-Alone Cervical51-1610072026-05-31
M711511610120Endeavor™ Stand-Alone Cervical51-1610122026-05-31
M711511611070Endeavor™ Stand-Alone Cervical51-1611072026-05-31
M711511611120Endeavor™ Stand-Alone Cervical51-1611122026-05-31
M711511612070Endeavor™ Stand-Alone Cervical51-1612072026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956232792CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
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10198956359611CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956364837CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956368002CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956392755CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956408401CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956439726CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956442450CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956448308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956448483CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956458291CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956461512CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956475328CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956481367CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956484269CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956487314CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956489875CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956504424CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956504776CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956504806CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956505490CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956505704CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956506909CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956507685CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508019CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508170CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509382CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509603CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956510418CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16