Impactor Handle

GUDID M209152590

BIOPRO, INC.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device IDM209152590
NIH Device Record Key59477fa5-04fa-4a64-a20c-01fe9f00c5fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameImpactor Handle
Version Model Number15259
Company DUNS618749857
Company NameBIOPRO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM209152590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWAImpactor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


[M209152590]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-09
Device Publish Date2019-05-01

On-Brand Devices [Impactor Handle]

M20915259015259
0081001248571515259

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