ASY-01065

GUDID 00840200409117

Locking Rod Driver

Integrity Implants Inc.

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable
Primary Device ID00840200409117
NIH Device Record Key4c97b284-7e71-4e53-b6cc-a8df16a5cc90
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberASY-01065
Catalog NumberASY-01065
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840200409117 [Primary]

FDA Product Code

HXXScrewdriver

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

[00840200409117]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-21
Device Publish Date2023-06-13

Devices Manufactured by Integrity Implants Inc.

00840200409759 - N/A2024-04-01 COMPRESSOR - COUNTER TORQUE ATTACHMENT
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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