Healix

GUDID 00810005662345

Washer 3.0-3.5mm. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Orthopaedic bone washer, non-sterile
Primary Device ID00810005662345
NIH Device Record Key571d4b95-4c93-4737-bd56-9e4b34ab11aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealix
Version Model NumberCSRW-WASH-335
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com
Phone(210) 545-3713
Emaildiana@nvisionbiomed.com

Device Dimensions

Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter
Outer Diameter7.64 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810005662345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

[00810005662345]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-20
Device Publish Date2019-09-30

On-Brand Devices [Healix]

00810005666916Cann. Headed Screw 2.5mmD, 28mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666428Solid Headed Screw 4.0mmD, 50mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666411Solid Headed Screw 4.0mmD, 48mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666404Solid Headed Screw 4.0mmD, 46mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666398Solid Headed Screw 4.0mmD, 44mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666381Solid Headed Screw 4.0mmD, 42mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666374Solid Headed Screw 4.0mmD, 40mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666367Solid Headed Screw 4.0mmD, 38mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666350Solid Headed Screw 4.0mmD, 36mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666343Solid Headed Screw 4.0mmD, 34mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666336Solid Headed Screw 4.0mmD, 32mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666329Solid Headed Screw 4.0mmD, 30mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666312Solid Headed Screw 4.0mmD, 28mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666305Solid Headed Screw 4.0mmD, 26mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666299Solid Headed Screw 4.0mmD, 24mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666282Solid Headed Screw 4.0mmD, 22mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666275Solid Headed Screw 4.0mmD, 20mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666268Solid Headed Screw 4.0mmD, 18mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666251Solid Headed Screw 3.5mmD, 40mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666244Solid Headed Screw 3.5mmD, 38mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666237Solid Headed Screw 3.5mmD, 36mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666220Solid Headed Screw 3.5mmD, 34mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666213Solid Headed Screw 3.5mmD, 32mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666206Solid Headed Screw 3.5mmD, 30mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666190Solid Headed Screw 3.5mmD, 26mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666183Solid Headed Screw 3.5mmD, 28mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666176Solid Headed Screw 3.5mmD, 24mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666169Solid Headed Screw 3.5mmD, 22mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666152Solid Headed Screw 3.5mmD, 20mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666145Solid Headed Screw 3.5mmD, 18mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666138Solid Headed Screw 3.5mmD, 16mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666121Solid Headed Screw 3.0mmD, 40mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666114Solid Headed Screw 3.0mmD, 38mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666107Solid Headed Screw 3.0mmD, 36mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666091Solid Headed Screw 3.0mmD, 34mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666084Solid Headed Screw 3.0mmD, 32mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666077Solid Headed Screw 3.0mmD, 30mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666060Solid Headed Screw 3.0mmD, 28mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666053Solid Headed Screw 3.0mmD, 26mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666046Solid Headed Screw 3.0mmD, 24mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666039Solid Headed Screw 3.0mmD, 22mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666022Solid Headed Screw 3.0mmD, 20mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666015Solid Headed Screw 3.0mmD, 18mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005666008Solid Headed Screw 3.0mmD, 16mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005665995Solid Headed Screw 3.0mmD, 14mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005665988Solid Headed Screw 3.0mmD, 12mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005665971Solid Headed Screw 3.0mmD, 10mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005665964Solid Headed Screw 2.5mmD, 30mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005665957Solid Headed Screw 2.5mmD, 28mmL The HEALIX Compression Screw (HCS) System is indicated for Bon
00810005665940Solid Headed Screw 2.5mmD, 26mmL The HEALIX Compression Screw (HCS) System is indicated for Bon

Trademark Results [Healix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEALIX
HEALIX
98675434 not registered Live/Pending
Healix Infusion Therapy, Inc.
2024-07-31
HEALIX
HEALIX
98581586 not registered Live/Pending
Brainstorm Industries, LLC
2024-06-03
HEALIX
HEALIX
98073918 not registered Live/Pending
Healix Clinical Laboratory LLC
2023-07-06
HEALIX
HEALIX
97113462 not registered Live/Pending
Sciessent LLC
2021-11-08
HEALIX
HEALIX
88731594 not registered Live/Pending
Ubican Global Licensing, LLC
2019-12-18
HEALIX
HEALIX
87931155 not registered Dead/Abandoned
NVision Biomedical Technologies, LLC
2018-05-22
HEALIX
HEALIX
87080602 not registered Dead/Abandoned
Medtronic, Inc.
2016-06-22
HEALIX
HEALIX
85938034 not registered Dead/Abandoned
Advanced Suture, Inc.
2013-05-21
HEALIX
HEALIX
85932954 not registered Dead/Abandoned
Haber, Jeff
2013-05-15
HEALIX
HEALIX
85852688 4435372 Live/Registered
HEALIX INFUSION THERAPY, LLC
2013-02-18
HEALIX
HEALIX
85822252 not registered Dead/Abandoned
Healix International Limited
2013-01-14
HEALIX
HEALIX
78232622 3101469 Live/Registered
HEALIX INFUSION THERAPY, LLC
2003-04-01
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