FTHPKW2

GUDID 00810004728776

1.4 mm Pointed Kirschner wire, NiTi

INTEGRITY IMPLANTS INC.

Spinal guidewire Spinal guidewire Spinal guidewire Spinal guidewire
Primary Device ID00810004728776
NIH Device Record Key51215683-596f-40e7-be17-daf588ea3ae0
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberASY-00462
Catalog NumberFTHPKW2
Company DUNS080300717
Company NameINTEGRITY IMPLANTS INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800.201.9300
Emailcustomerservice@integrityimplants.com
Phone800.201.9300
Emailcustomerservice@integrityimplants.com
Phone800.201.9300
Emailcustomerservice@integrityimplants.com
Phone800.201.9300
Emailcustomerservice@integrityimplants.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810004728776 [Primary]
GS100810004728776 [Primary]
GS100810004728776 [Primary]
GS100810004728776 [Primary]

FDA Product Code

HXIPasser, Wire, Orthopedic
HXIPasser, Wire, Orthopedic
HXIPasser, Wire, Orthopedic
HXIPasser, Wire, Orthopedic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810004728776]

Moist Heat or Steam Sterilization


[00810004728776]

Moist Heat or Steam Sterilization


[00810004728776]

Moist Heat or Steam Sterilization


[00810004728776]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

Devices Manufactured by INTEGRITY IMPLANTS INC.

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00810004728899 - N/A2020-05-25 Tubular Retractor #1 - Beveled, 140mm, FH7 ENDO
00810004728905 - N/A2020-05-25 Tubular Retractor #2 - Beaked, 140mm, FH7 ENDO
00810004728912 - N/A2020-05-25 Tubular Retractor #5 - Beaked, 140mm, FH7 ENDO
00810004728929 - N/A2020-05-25 Tubular Retractor #3 - Beveled, 140mm, FH7 ENDO
00810004727854 - N/A2020-05-21 10" Toothed Pituitary Rongeur, 4mm Straight
00810004727861 - N/A2020-05-21 10" Toothed Pituitary Rongeur 3mm Straight

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