N/A ASY-00067

GUDID 00818613021530

Straight Curette, Ring Size #3 Up Angled Curette, Ring Size #3

INTEGRITY IMPLANTS INC.

Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable
Primary Device ID00818613021530
NIH Device Record Key83f13cfe-ca1c-41fa-bff7-ccf48fbf1170
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberASY-00067
Catalog NumberASY-00067
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

Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100818613021530 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


[00818613021530]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-07
Device Publish Date2018-09-12

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.