GPC

GUDID 08905892007095

intraHEAL Proximal Hip Stabilizing Nail - Titanium, Dia. 11 mm, 200 mm Length

GPC MEDICAL LIMITED

Arthrodesis nail, fixed-length
Primary Device ID08905892007095
NIH Device Record Key4f90eb42-fd87-4d48-bf41-21a2cb200779
Commercial Distribution StatusIn Commercial Distribution
Brand NameGPC
Version Model NumberILBS59-T
Company DUNS915882579
Company NameGPC MEDICAL LIMITED
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com
Phone9205302602
Emailinfo@gpcmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108905892007095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

[08905892007095]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-08
Device Publish Date2023-11-30

On-Brand Devices [GPC]

08905892018251intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 10 mm,360 mm Length
08905892018244intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 10 mm,340 mm Length
08905892018237intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 10 mm,320 mm Length
08905892018220intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 10 mm, 300 mm Length
08905892018213intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 10 mm, 280 mm Length
08905892018206intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 10 mm, 260 mm Length.
08905892018190intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 10 mm, 260 mm Length
08905892018183intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 9 mm, 340 mm Length
08905892018176intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 9 mm, 320 mm Length
08905892018169intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 9 mm, 300 mm Length
08905892018152intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 9 mm, 280 mm Length
08905892018145intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 9 mm, 260 mm Length
08905892018138intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 8 mm, 360 mm Length
08905892018121intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 8 mm, 340 mm Length
08905892018114intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 8 mm, 320 mm Length
08905892018107intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 8 mm, 300 mm Length
08905892018091intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 8 mm, 280 mm Length
08905892018084intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 8 mm,260 mm Length
08905892018077intraHEAL Multi Angle Tibial Nail - S.S., Dia. 10 mm, 360 mm Length
08905892018060intraHEAL Multi Angle Tibial Nail - S.S., Dia. 10 mm, 340 mm Length
08905892018053intraHEAL Multi Angle Tibial Nail - S.S., Dia. 10 mm, 320 mm Length
08905892018046intraHEAL Multi Angle Tibial Nail - S.S., Dia. 10 mm, 300 mm Length.
08905892018039intraHEAL Multi Angle Tibial Nail - S.S., Dia. 10 mm, 280 mm Length
08905892018022intraHEAL Multi Angle Tibial Nail - S.S., Dia. 10 mm, 260 mm Length.
08905892018015intraHEAL Multi Angle Tibial Nail - S.S.,Dia. 9 mm, 360 mm Length
08905892018008intraHEAL Multi Angle Tibial Nail - S.S., Dia. 9 mm, 340 mm Length
08905892017995intraHEAL Multi Angle Tibial Nail - S.S., Dia. 9 mm, 320 mm Length
08905892017988intraHEAL Multi Angle Tibial Nail - S.S., Dia. 9 mm, 300 mm Length
08905892017971intraHEAL Multi Angle Tibial Nail - S.S., Dia. 9 mm, 280 mm Length
08905892017964intraHEAL Multi Angle Tibial Nail - S.S., Dia. 9 mm, 260 mm Length.
08905892017957intraHEAL Multi Angle Tibial Nail - S.S., Dia. 8 mm, 360 mm Length
08905892017940intraHEAL Multi Angle Tibial Nail - S.S., Dia. 8 mm, 340 mm Length
08905892017933intraHEAL Multi Angle Tibial Nail - S.S., Dia. 8 mm, 320 mm Length
08905892017926intraHEAL Multi Angle Tibial Nail - S.S., Dia. 8 mm, 300 mm Length
08905892017919intraHEAL Multi Angle Tibial Nail - S.S., MLTN08, 280 mm Length
08905892017902intraHEAL Multi Angle Tibial Nail - S.S., Dia. 8 mm, 260 mm Length
08905892008092intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 12 mm, 440 mm Length
08905892008085intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 12 mm, 420 mm Length
08905892008078intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 12 mm, 400 mm Length
08905892008061intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 12 mm, 380 mm Length
08905892008054intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 12 mm, 360 mm Length
08905892008047intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 12 mm, 340 mm Length
08905892008030intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 12 mm, 320 mm Length
08905892008023intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 12 mm, 300 mm Length
08905892008016intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 11 mm, 440 mm Length
08905892008009intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 11 mm, 420 mm Length
08905892007996intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 11 mm, 400 mm Length
08905892007989intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 11 mm, 380 mm Length
08905892007972intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 11 mm, 360 mm Length
08905892007965intraHEAL Proximal Hip Stabilizing Nail, Long - Titanium - Right, Dia. 11 mm, 340 mm Length
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.