FDA.reportPublic FDA data

Excella®

Primary DI
M711BPS040
Brand
Excella®
Company
INNO Holdings, Inc.
Model
BPS-04
Device description
Radel, Tecapro, Al, SST
Published
2022-10-24
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
M711BPS040PrimaryHIBCC0

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
M711LB0720L-Box®LB-072LB-0722019-07-05
M711LB0730L-Box®LB-073LB-0732019-07-05
M711LB1340L-Box®LB-134LB-1342019-07-05
M711LB1350L-Box®LB-135LB-1352019-07-05
M711LS5530TruView™LS-5532022-03-31
M711511409070Endeavor™ Stand-Alone Cervical51-1409072026-05-01
M71151010Endeavor™ Stand-Alone Cervical51-012026-04-30
M711511406070Endeavor™ Stand-Alone Cervical51-1406072026-04-30
M711511407070Endeavor™ Stand-Alone Cervical51-1407072026-04-30
M711511407120Endeavor™ Stand-Alone Cervical51-1407122026-04-30
M711511408070Endeavor™ Stand-Alone Cervical51-1408072026-04-30
M711511408120Endeavor™ Stand-Alone Cervical51-1408122026-04-30
M711511409120Endeavor™ Stand-Alone Cervical51-1409122026-04-30
M711AXTI55350AxTiHA®AXTi5535AXTi55352026-03-31
M711AXTI55400AxTiHA®AXTi5540AXTi55402026-03-31
M711AXTI65350AxTiHA®AXTi6535AXTi65352026-03-31
M711AXTI65400AxTiHA®AXTi6540AXTi65402026-03-31
M711LS7980Navigation - Vector™ G-ELS-7982026-03-31
M711LA1120Excella®LA-1122024-01-31
M711LA1130Excella®LA-1132024-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489203493Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
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10193489212549Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489212884Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213027Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213072Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213447Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213737Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213911Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213935Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213966Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214048Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214130Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214406Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214413Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214499Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214512Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214697Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489215366Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489215465Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216158Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216165Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216455Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489217117Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489217711Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08