GTC®

GUDID M433GTCDTSL1

GTC Dental Tray (Large), 5/Set

INTEGRA LIFESCIENCES CORPORATION

Stereotactic radiosurgical invasive head frame
Primary Device IDM433GTCDTSL1
NIH Device Record Keyfcf4e01f-ea80-4460-8054-f9dabb695c37
Commercial Distribution StatusIn Commercial Distribution
Brand NameGTC®
Version Model NumberGTCDTSL
Company DUNS963856096
Company NameINTEGRA LIFESCIENCES CORPORATION
Device Count5
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100381780252750 [Unit of Use]
GS110381780252757 [Primary]
HIBCCM433GTCDTSL1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-13
Device Publish Date2016-07-26

On-Brand Devices [GTC®]

M433OP1Occipital Putty
M433GTCSVS1Velcro Strap 5/Set
M433GTCOCP1GTC Occipital Plate (Plastic)
M433GTCDTSS1GTC Dental Tray (Small), 5/Set
M433GTCDTSM1GTC Dental Tray (Medium), 5/Set
M433GTCDTSL1GTC Dental Tray (Large), 5/Set
M433GTCDPS10U1GTC Bent Dental Plate - 10 Degrees Up (Small)
M433GTCDPS10D1GTC Bent Dental Plate - 10 Degrees Down (Small)
M433GTCDPS1GTC Dental Plate (Short)
M433GTCDPM10U1GTC Bent Dental Plate - 10 Degrees UP (Medium)
M433GTCDPM10D1GTC Bent Dental Plate - 10 Degrees Down (Medium)
M433GTCDMP1GTC Dental Plate (Medium)
M433GTCDPL1GTC Dental Plate (Long)
M433GTCDIMU1GTC Dental Impression Material Upgrade
M433GTCDDU1GTC Dental Dispenser Upgrade

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