ASY-00520

GUDID 00810004729117

Crosslink Set Screw Final 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
Primary Device ID00810004729117
NIH Device Record Key2ba0f619-2af3-4495-9991-018a4335eb2c
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberASY-00520
Catalog NumberASY-00520
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810004729117 [Primary]
GS100810004729117 [Primary]
GS100810004729117 [Primary]
GS100810004729117 [Primary]
GS100810004729117 [Primary]
GS100810004729117 [Primary]
GS100810004729117 [Primary]
GS100810004729117 [Primary]
GS100810004729117 [Primary]
GS100810004729117 [Primary]
GS100810004729117 [Primary]
GS100810004729117 [Primary]
GS100810004729117 [Primary]
GS100810004729117 [Primary]

FDA Product Code

HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


[00810004729117]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

Devices Manufactured by INTEGRITY IMPLANTS INC.

00810004729117 - NA2020-09-14Crosslink Set Screw Final Driver
00810004729117 - NA2020-09-14 Crosslink Set Screw Final Driver
00810004729049 - N/A2020-07-21 Tubular Retractor #1 - Beveled, 200mm, FH7 ENDO
00810004729056 - N/A2020-07-21 Tubular Retractor #2 - Beaked, 200mm, FH7 ENDO
00810004729063 - N/A2020-07-21 Tubular Retractor #3 - Beveled, 200mm, FH7 ENDO
00810004729070 - N/A2020-07-21 7mm Shaver, FH7 ENDO
00810004729087 - N/A2020-07-21 8mm Shaver, FH7 ENDO
00810004729094 - N/A2020-07-21 9mm Shaver, FH7 ENDO
00810004721999 - N/A2020-07-17 Articulating Curette, FH7

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