HALLU-FIX HALUINSTSET

GUDID 10381780064404

The Hallu-Fix set includes Hallu-Fix S Plates, Hallu-Fix C Plates, screws, and instruments. The Hallu Plates are low profile titanium plates dedicated to first metatarsophalangeal arthrodesis. The system is intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint.

NEWDEAL

General internal orthopaedic fixation system implantation kit
Primary Device ID10381780064404
NIH Device Record Key02e16aba-bece-4414-97a2-7cb2b69c9ac9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHALLU-FIX
Version Model NumberHALUINSTSET
Catalog NumberHALUINSTSET
Company DUNS536935331
Company NameNEWDEAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780064404 [Primary]
HIBCCM248HALUINSTSET1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

[10381780064404]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-16
Device Publish Date2015-09-22

On-Brand Devices [HALLU-FIX]

10381780064404The Hallu-Fix set includes Hallu-Fix S Plates, Hallu-Fix C Plates, screws, and instruments. The
10381780043584The sterile HALLU-C plates are available in different sizes (left/right). They are both low prof
10381780043577The non sterile HALLU-C plates are available in different sizes (left/right). They are both low
10381780043560The sterile HALLU-C plates are available in different sizes (left/right). They are both low prof
10381780043553The non sterile HALLU-C plates are available in different sizes (left/right). They are both low
10381780043546The sterile HALLU-C plates are available in different sizes (left/right). They are both low prof
10381780043539The non sterile HALLU-C plates are available in different sizes (left/right). They are both low
10381780043522The sterile HALLU-C plates are available in different sizes (left/right). They are both low prof
10381780043515The non sterile HALLU-C plates are available in different sizes (left/right). They are both low
10381780043508The sterile HALLU-C plates are available in different sizes (left/right). They are both low prof
10381780043492The non sterile HALLU-C plates are available in different sizes (left/right). They are both low
10381780043485The sterile HALLU-C plates are available in different sizes (left/right). They are both low prof
10381780043478The non sterile HALLU-C plates are available in different sizes (left/right). They are both low
10381780043461The sterile HALLU-S plates are available in different sizes (left/right). They are both low prof
10381780043454The non sterile HALLU-S plates are available in different sizes (left/right). They are both low
10381780043447The sterile HALLU-S plates are available in different sizes (left/right). They are both low prof
10381780043430The non sterile HALLU-S plates are available in different sizes (left/right). They are both low
10381780043423The sterile HALLU-S plates are available in different sizes (left/right). They are both low prof
10381780043416The non sterile HALLU-S plates are available in different sizes (left/right). They are both low
10381780043409The sterile HALLU-S plates are available in different sizes (left/right). They are both low prof
10381780043393The non sterile HALLU-S plates are available in different sizes (left/right). They are both low
10381780043386The sterile HALLU-S plates are available in different sizes (left/right). They are both low prof
10381780043379The non sterile HALLU-S plates are available in different sizes (left/right). They are both low
10381780043362The sterile HALLU-S plates are available in different sizes (left/right). They are both low prof
10381780043355The non sterile HALLU-S plates are available in different sizes (left/right). They are both low
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