ASY-00720

GUDID 00810045534572

Rocker 5.5/6.0mm Tulip- Extended Window

INTEGRITY IMPLANTS INC.

Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer
Primary Device ID00810045534572
NIH Device Record Key9aea4f50-7212-4eaa-be07-5790f829ee40
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberASY-00720
Catalog NumberASY-00720
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [Primary]
GS100810045534572 [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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


[00810045534572]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

Devices Manufactured by INTEGRITY IMPLANTS INC.

00840200403160 - NA2021-01-18 Anti-Splay Cap, 5.5 -6.0
00810045534572 - NA2021-01-13Rocker 5.5/6.0mm Tulip- Extended Window
00810045534572 - NA2021-01-13 Rocker 5.5/6.0mm Tulip- Extended Window
00810004729018 - NA2020-12-24 Expandable Shaver, FH7
00810004729025 - NA2020-12-24 Shaver Blade Assembly
00810004729421 - N/A2020-12-23 Small Curette
00810004729445 - N/A2020-12-23 Large Curette
00810004729452 - N/A2020-12-23 Small Up Curette
00810004729476 - N/A2020-12-23 Large Up Curette

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