ASY-00726

GUDID 00810045534626

Fixed T-Handle

INTEGRITY IMPLANTS INC.

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device ID00810045534626
NIH Device Record Key49cbfff9-45ca-4386-9c2e-c17ca8191014
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberASY-00726
Catalog NumberASY-00726
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
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
GS100810045534626 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

[00810045534626]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-15
Device Publish Date2021-07-07

Devices Manufactured by INTEGRITY IMPLANTS INC.

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00840200409537 - LineSider2024-03-12 MIS Fixed Rod Inserter
00840200409667 - LineSider2024-03-12 MIS Rod Inserter Locking Shaft
00840200409735 - LineSider2024-03-12 MIS Fixed Rod Inserter, Winged
00840200408790 - N/A2024-02-14 Vertebral Body Spreader
00840200408806 - N/A2024-02-14 Finger Pad, Right
00840200408813 - N/A2024-02-14 Finger Pad, Left
00840200409339 - N/A2024-02-07 1.5mm KIRSCHNER WIRE XL, 316SS, THREADED, TROCAR TIP
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