PROFEMUR TL2 PRTL2BP8

GUDID M684PRTL2BP81

PROFEMUR TL2 BROACH SZ 8+

Microport Orthopedics Inc.

Femoral stem prosthesis trial
Primary Device IDM684PRTL2BP81
NIH Device Record Key7ab7d210-5dc6-4528-97c5-6dbd365e63b7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROFEMUR TL2
Version Model NumberPRTL2BP8
Catalog NumberPRTL2BP8
Company DUNS079118736
Company NameMicroport Orthopedics Inc.
Device Count1
DM Exempttrue
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

Customer Support Contacts

Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192629396180 [Primary]
HIBCCM684PRTL2BP81 [Secondary]

FDA Product Code

HWTTEMPLATE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M684PRTL2BP81]

Moist Heat or Steam Sterilization


[M684PRTL2BP81]

Moist Heat or Steam Sterilization


[M684PRTL2BP81]

Moist Heat or Steam Sterilization


[M684PRTL2BP81]

Moist Heat or Steam Sterilization


[M684PRTL2BP81]

Moist Heat or Steam Sterilization


[M684PRTL2BP81]

Moist Heat or Steam Sterilization


[M684PRTL2BP81]

Moist Heat or Steam Sterilization


[M684PRTL2BP81]

Moist Heat or Steam Sterilization


[M684PRTL2BP81]

Moist Heat or Steam Sterilization


[M684PRTL2BP81]

Moist Heat or Steam Sterilization


[M684PRTL2BP81]

Moist Heat or Steam Sterilization


[M684PRTL2BP81]

Moist Heat or Steam Sterilization


[M684PRTL2BP81]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-21
Device Publish Date2024-03-13

On-Brand Devices [PROFEMUR TL2]

M684PRTL2BP91PROFEMUR TL2 BROACH SZ 9+
M684PRTL2BP81PROFEMUR TL2 BROACH SZ 8+
M684PRTL2BP51PROFEMUR TL2 BROACH SZ 5+
M684PRTL2EP91PROFEMUR® TL2 STEM SZ 9+ HIGH OFFSET NECK
M684PRTL2EP81PROFEMUR® TL2 STEM SZ 8+ HIGH OFFSET NECK
M684PRTL2EP51PROFEMUR TL2 STEM SZ 5+ HIGH OFFSET NECK
M684PRTL2SP91PROFEMUR TL2 STEM SZ 9+ STANDARD NECK
M684PRTL2SP81PROFEMUR TL2 STEM SZ 8+ STANDARD NECK
M684PRTL2SP51PROFEMUR TL2 STEM SZ 5+ STANDARD NECK

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