FDA.reportPublic FDA data

L-Box®

Primary DI
M711LB0830
Brand
L-Box®
Company
INNO Holdings, Inc.
Model
LB-083
Catalog number
LB-083
Device description
SST
Published
2018-08-03
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
HXDClamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LB0830PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical table clampA device that is designed to be used together with operating tables and certain kinds of examination/treatment tables. It can have different fixation/locking mechanisms, but is often designed to fit onto the side rails of such tables. It is used to hold different components and accessories onto the table providing added functionality. Such devices can be footrests, transducer holders, anaesthesia screen holders. The clamp allows for easy and safe adjustments of the position of these accessory devices and provides a secure locking mechanism. 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
DM exempt
true
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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M711LS7490Vector™ Pedicle Screw SystemLS-7492026-06-05
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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
B8034503260ORTHOMEDORTHO-MED, INC.HXD2026-07-14
B8034503660ORTHOMEDORTHO-MED, INC.HXD2026-07-14
B8034503700ORTHOMEDORTHO-MED, INC.HXD2026-07-14
00840277133656Innomed, Inc.INNOMED, INC.HXD2026-05-29
ESAM3840131STOMA®Storz am Mark GmbHHXD2025-04-30
ESAM3841131STOMA®Storz am Mark GmbHHXD2025-04-30
14026704918680PILLINGTELEFLEX INCORPORATEDHXD2024-07-15
14026704918727PILLINGTELEFLEX INCORPORATEDHXD2024-07-15
10840199539571Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539588Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539595Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539601Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539618Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539625Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539632Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539649Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199535894ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535948Cardio ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535955Cardio ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535979Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536013Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536020Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536037Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199539410Thoracic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199539694Dietrich Micro Coronary BulldogKOROS U.S.A., INC.HXD2024-01-31
10840199539724DeBakey Bulldog ClampsKOROS U.S.A., INC.HXD2024-01-31
10840199539731DeBakey Bulldog ClampsKOROS U.S.A., INC.HXD2024-01-31
10840199539748DeBakey Bulldog ClampsKOROS U.S.A., INC.HXD2024-01-31
10840199539755DeBakey Bulldog ClampsKOROS U.S.A., INC.HXD2024-01-31
10840199539762DeBakey Bulldog ClampsKOROS U.S.A., INC.HXD2024-01-31