ASY-00701

GUDID 00810004721920

Hudson to 1/4 drive

INTEGRITY IMPLANTS INC.

Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable
Primary Device ID00810004721920
NIH Device Record Key302443ba-a405-4689-9713-3f69fbd6aaf0
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberASY-00701
Catalog NumberASY-00701
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
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]
GS100810004721920 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


[00810004721920]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-22
Device Publish Date2021-02-12

Devices Manufactured by INTEGRITY IMPLANTS INC.

00810004728769 - NA2021-03-01 MIS Comp/Dis Pivot Block 20mm
00818613022544 - LineSider2021-03-01 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated - 5.5mm x 25mm
00818613022551 - LineSider2021-03-01 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated - 5.5mm x 30mm
00818613022568 - LineSider2021-03-01 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated - 5.5mm x 35mm
00818613022575 - LineSider2021-03-01 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated - 5.5mm x 40mm
00818613022582 - LineSider2021-03-01 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated - 5.5mm x 45mm
00818613022599 - LineSider2021-03-01 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated - 5.5mm x 50mm
00818613022605 - LineSider2021-03-01 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated - 5.5mm x 55mm

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