Slotted Pin Puller 8829003010

GUDID 00843575108739

B-ONE ORTHO, CORP.

Orthopaedic implant inserter/extractor, reusable

Primary Device ID	00843575108739
NIH Device Record Key	118f18bf-a7a5-4172-a6c2-6ec738a32989
Commercial Distribution Status	In Commercial Distribution
Brand Name	Slotted Pin Puller
Version Model Number	8829003010
Catalog Number	8829003010
Company DUNS	081315444
Company Name	B-ONE ORTHO, CORP.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843575108739 [Primary]

FDA Product Code

LXH	Orthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

[00843575108739]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-03-15
Device Publish Date	2024-03-07

Devices Manufactured by B-ONE ORTHO, CORP.

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00843575127167 - MOBIO™ Total Knee System	2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 11MM thickness, Standard UHMWPE
00843575127174 - MOBIO™ Total Knee System	2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 13MM thickness, Standard UHMWPE
00843575127181 - MOBIO™ Total Knee System	2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 16MM thickness, Standard UHMWPE
00843575127198 - MOBIO™ Total Knee System	2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 19MM thickness, Standard UHMWPE
00843575127204 - MOBIO™ Total Knee System	2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 22MM thickness, Standard UHMWPE
00843575127211 - MOBIO™ Total Knee System	2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 25MM thickness, Standard UHMWPE

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