N/A ASY-00390

GUDID 00810004727861

10" Toothed Pituitary Rongeur 3mm Straight

INTEGRITY IMPLANTS INC.

Spinal rongeur Spinal rongeur Spinal rongeur
Primary Device ID00810004727861
NIH Device Record Key8e035f57-b2b6-423e-936c-a5e479f304de
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberASY-00390
Catalog NumberASY-00390
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 Usefalse
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
Emailinfo@integrityimplants.com
Phone800-201-9300
Emailinfo@integrityimplants.com
Phone800-201-9300
Emailinfo@integrityimplants.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810004727861 [Primary]
GS100810004727861 [Primary]
GS100810004727861 [Primary]

FDA Product Code

HTXRongeur
HTXRongeur
HTXRongeur

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810004727861]

Moist Heat or Steam Sterilization


[00810004727861]

Moist Heat or Steam Sterilization


[00810004727861]

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

On-Brand Devices [N/A]

00810004722323FlareHawk Universal Instrument Tray
00810004721883Pedicle Rod Inserter
00810004721746Handled Double Ended Set Screw Starter
00810004721739Self Retaining Screw Driver - Split Ring Style
0081861302732715mm Distractor
0081861302731014mm Distractor
0081861302730313mm Distractor
0081861302729712mm Distractor
0081861302728011mm Distractor
0081861302727310mm Distractor
008186130272669mm Distractor
008186130272598mm Distractor
008186130272427mm Distractor
00818613021547Lateral Curette, Ring Size #3 Up Angled Curette, Ring Size #3
00818613021530Straight Curette, Ring Size #3 Up Angled Curette, Ring Size #3
00818613021523Down Pushing Curette Up Angled Curette, Ring Size #3
00818613021516Up Angled Curette, Ring Size #3 Up Angled Curette, Ring Size #3
00818613021455VS Bone Funnel
00818613021448VS Bone Tamp
00818613021257Tall Obturator Impactor
00818613021240Short Obturator Impactor
00818613021172Implant Tamp
0081861302114116cm Offset Graft Guide
0081861302113416cm Straight Graft Guide
00818613021066Straight Rasp
0081861302105930 Degree Bent Rasp
00818613021035Tall Cannula
00818613021028Short Cannula
008186130210113.25mm Rasp
00818613020946CMP-00043 GB Impactor
00818613020922CMP-00023 GB Cannula Tall
00818613020915GB Cannula Short
00818613020908CMP-00021 GB Dilator 2, Tall
00818613020892CMP-00020 GB Dilator 2, Short
00818613020885GB Dilator 1
00818613020878Shaver, 14mm
00818613020861Shaver, 13mm
00818613020854Shaver, 12mm
00818613020847Shaver, 11mm
00818613020830Shaver, 10mm
00818613020823Shaver, 9mm
00818613020816Shaver, 8mm
00818613020809Shaver, 7mm
00818613020601Split Shim Removal Tool
00818613020502CR 9.5MM ANGLED UTERINE CURETTE (Ring Curette)
00818613020496Distractor size 14mm
00818613020489Distractor size 13mm
00818613020472Distractor size 12mm
00818613020465Distractor size 11mm

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