b-ONE Hip Instrumentation 8819065000

GUDID 00843575106711

Offset Rasp

B-ONE ORTHO, CORP.

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device ID00843575106711
NIH Device Record Keyeb755466-a069-42f4-add1-1f3f7e2c7d82
Commercial Distribution StatusIn Commercial Distribution
Brand Nameb-ONE Hip Instrumentation
Version Model Number8819065000
Catalog Number8819065000
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
GS100843575106711 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843575106711]

Moist Heat or Steam Sterilization


[00843575106711]

Moist Heat or Steam Sterilization


[00843575106711]

Moist Heat or Steam Sterilization


[00843575106711]

Moist Heat or Steam Sterilization


[00843575106711]

Moist Heat or Steam Sterilization


[00843575106711]

Moist Heat or Steam Sterilization


[00843575106711]

Moist Heat or Steam Sterilization


[00843575106711]

Moist Heat or Steam Sterilization


[00843575106711]

Moist Heat or Steam Sterilization


[00843575106711]

Moist Heat or Steam Sterilization


[00843575106711]

Moist Heat or Steam Sterilization


[00843575106711]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-23
Device Publish Date2020-09-15

On-Brand Devices [b-ONE Hip Instrumentation ]

00843575106650Left Dual Offset Broach Handle
00843575106643Right Dual Offset Broach Handle
00843575108623b-ONE Instrument Tray, Main Body
00843575108616b-ONE Instrument Tray
00843575106711Offset Rasp
00843575106704Starter Broach
00843575106698Stem Remover, Non-Modular
00843575106681Offset Cookie Cutter
00843575106674Curved Inserter, Non-Modular
00843575106667Straight Stem Impactor, Non-Modular

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