ASY-00898

GUDID 00840200406024

Teardrop Bone Tamp, FH9

INTEGRITY IMPLANTS INC.

Surgical tamp, reusable
Primary Device ID00840200406024
NIH Device Record Key80453e5b-65a8-4961-88e3-34f2ae82311d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberASY-00898
Catalog NumberASY-00898
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
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
Phone800-201-9300
Emailcustomerservice@integrityimplants.com
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
GS100840200406024 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


[00840200406024]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-09
Device Publish Date2021-12-01

Devices Manufactured by INTEGRITY IMPLANTS INC.

00840200405492 - NA2024-09-09 BH Tapered Screw Starter
00840200410045 - N/A2024-07-18 SS Right Blade, 80mm
00840200410052 - N/A2024-07-18 SS Right Blade, 70mm
00840200410069 - N/A2024-07-18 SS Right Blade, 60mm
00840200410076 - N/A2024-07-18 SS Right Blade, 50mm
00840200410083 - N/A2024-07-18 SS Left Blade, 80mm
00840200410090 - N/A2024-07-18 SS Left Blade, 70mm
00840200410106 - N/A2024-07-18 SS Left Blade, 60mm

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