b-ONE Hip Specialty 8819P00001

GUDID 00843575121219

Broach Box Chisel

B-ONE ORTHO, CORP.

Orthopaedic chisel
Primary Device ID00843575121219
NIH Device Record Keyf858fd90-2748-4a32-8fac-4a8b92ddb13a
Commercial Distribution StatusIn Commercial Distribution
Brand Nameb-ONE Hip Specialty
Version Model Number8819P00001
Catalog Number8819P00001
Company DUNS081315444
Company NameB-ONE ORTHO, CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100843575121219 [Primary]

FDA Product Code

HTSKnife, Orthopedic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


[00843575121219]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-30
Device Publish Date2025-01-22

Devices Manufactured by B-ONE ORTHO, CORP.

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00843575124531 - Mobio™ Specialty 2025-02-20 TIBIAL TRIAL PLATE, SIZE E
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