Genie RCR Instruments

GUDID 08809399748546

Ø5.25 Reusable AWL(Healmax)

OSTEONIC CO.,Ltd.

Bone awl
Primary Device ID08809399748546
NIH Device Record Key7da7939f-5857-41f4-852b-ce7f4d00c1d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenie RCR Instruments
Version Model NumberBHA-5320-AWL
Company DUNS688999370
Company NameOSTEONIC CO.,Ltd.
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
GS108809399748546 [Primary]

FDA Product Code

HWJAwl

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809399748546]

Moist Heat or Steam Sterilization


[08809399748546]

Moist Heat or Steam Sterilization


[08809399748546]

Moist Heat or Steam Sterilization


[08809399748546]

Moist Heat or Steam Sterilization


[08809399748546]

Moist Heat or Steam Sterilization


[08809399748546]

Moist Heat or Steam Sterilization


[08809399748546]

Moist Heat or Steam Sterilization


[08809399748546]

Moist Heat or Steam Sterilization


[08809399748546]

Moist Heat or Steam Sterilization


[08809399748546]

Moist Heat or Steam Sterilization


[08809399748546]

Moist Heat or Steam Sterilization


[08809399748546]

Moist Heat or Steam Sterilization


[08809399748546]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-29
Device Publish Date2021-07-21

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08809595975517Ø4.5 Reusable Taperad TAP
08809399748560Ø4.5/4.8 Reusable AWL
08809399748553Ø4.75 Reusable Taperad TAP(Healmax)
08809399748546Ø5.25 Reusable AWL(Healmax)
08809399748539Ø5.25 Reusable Taperad TAP(Healmax)

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