46000101S

GUDID H98046000101S0

TI CRANIAL FLAP TUBE CLAMP 13MM DIA-STERILE

SYNTHES (U.S.A.) LP

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized
Primary Device IDH98046000101S0
NIH Device Record Key1149f2b2-233f-48d7-a034-f077b491ccbf
Commercial Distribution StatusIn Commercial Distribution
Version Model Number460.001.01S
Catalog Number46000101S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587054759 [Primary]
HIBCCH98046000101S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXNPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

[H98046000101S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-14

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