Profemur PGHCCE10

GUDID M684PGHCCE101

PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 10 EXT

Microport Orthopedics Inc.

Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis
Primary Device IDM684PGHCCE101
NIH Device Record Key82f87698-9b14-498e-80de-7280e011a057
Commercial Distribution StatusIn Commercial Distribution
Brand NameProfemur
Version Model NumberPGHCCE10
Catalog NumberPGHCCE10
Company DUNS079118736
Company NameMicroport Orthopedics Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100192629250390 [Primary]
GS100192629250390 [Primary]
GS100192629250390 [Primary]
GS100192629250390 [Primary]
GS100192629250390 [Primary]
GS100192629250390 [Primary]
GS100192629250390 [Primary]
GS100192629250390 [Primary]
HIBCCM684PGHCCE101 [Secondary]
HIBCCM684PGHCCE101 [Secondary]
HIBCCM684PGHCCE101 [Secondary]
HIBCCM684PGHCCE101 [Secondary]
HIBCCM684PGHCCE101 [Secondary]
HIBCCM684PGHCCE101 [Secondary]
HIBCCM684PGHCCE101 [Secondary]
HIBCCM684PGHCCE101 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Profemur]

M684PGHCCS101PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 10 STD
M684PGHCCLE71PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 7 EXT
M684PGHCCE101PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 10 EXT
M684PGHCCLE91PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 9 EXT
M684PGHCCLE81PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 8 EXT
M684PGHCCLE61PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 6 EXT
M684PGHCCLE51PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 5 EXT
M684PGHCCLE41PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 4 EXT
M684PGHCCLE31PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 3 EXT
M684PGHCCLE21PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 2 EXT
M684PGHCCLE11PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 1 EXT
M684PGHCCLS91PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 9 STD
M684PGHCCLS81PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 8 STD
M684PGHCCLS71PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 7 STD
M684PGHCCLS61PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 6 STD
M684PGHCCLS51PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 5 STD
M684PGHCCLS41PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 4 STD
M684PGHCCLS31PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 3 STD
M684PGHCCLS21PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 2 STD
M684PGHCCLS11PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 1 STD

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