ANTEGRA-T 03661134

GUDID H981036611340

TRIAL ANTEGRA-T PLATE LUMBAR/43MM

Synthes GmbH

Spinal implant trial
Primary Device IDH981036611340
NIH Device Record Key07740794-c596-4ba4-97b3-91aea37e130a
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTEGRA-T
Version Model Number03.661.134
Catalog Number03661134
Company DUNS486711679
Company NameSynthes GmbH
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

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
GS110705034721255 [Primary]
HIBCCH981036611340 [Secondary]

FDA Product Code

HWTTEMPLATE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H981036611340]

Moist Heat or Steam Sterilization

[H981036611340]

Moist Heat or Steam Sterilization

[H981036611340]

Moist Heat or Steam Sterilization

[H981036611340]

Moist Heat or Steam Sterilization

[H981036611340]

Moist Heat or Steam Sterilization

[H981036611340]

Moist Heat or Steam Sterilization

[H981036611340]

Moist Heat or Steam Sterilization

[H981036611340]

Moist Heat or Steam Sterilization

[H981036611340]

Moist Heat or Steam Sterilization

[H981036611340]

Moist Heat or Steam Sterilization

[H981036611340]

Moist Heat or Steam Sterilization

[H981036611340]

Moist Heat or Steam Sterilization

[H981036611340]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-26
Device Publish Date2016-12-31

On-Brand Devices [ANTEGRA-T]

H98104103053S0TI ANTEGRA-T PLATE-STERILE 53MM-50MM LENGTH-SACRAL
H98104103051S0TI ANTEGRA-T PLATE-STERILE 51MM-48MM LENGTH-SACRAL
H98104103049S0TI ANTEGRA-T PLATE-STERILE 49MM-46MM LENGTH-SACRAL
H98104103047S0TI ANTEGRA-T PLATE-STERILE 47MM-44MM LENGTH-SACRAL
H98104103045S0TI ANTEGRA-T PLATE-STERILE 45MM-42MM LENGTH-SACRAL
H98104103043S0TI ANTEGRA-T PLATE-STERILE 43MM-40MM LENGTH-SACRAL
H98104103041S0TI ANTEGRA-T PLATE-STERILE 41MM-38MM LENGTH-SACRAL
H98104103039S0TI ANTEGRA-T PLATE-STERILE 39MM-37MM LENGTH-SACRAL
H98104103037S0TI ANTEGRA-T PLATE-STERILE 37MM-35MM LENGTH-SACRAL
H98104102053S0TI ANTEGRA-T PLATE-STERILE 53MM-50MM LENGTH-LUMBAR
H98104102051S0TI ANTEGRA-T PLATE-STERILE 51MM-48MM LENGTH-LUMBAR
H98104102049S0TI ANTEGRA-T PLATE-STERILE 49MM-46MM LENGTH-LUMBAR
H98104102047S0TI ANTEGRA-T PLATE-STERILE 47MM-44MM LENGTH-LUMBAR
H98104102045S0TI ANTEGRA-T PLATE-STERILE 45MM-42MM LENGTH-LUMBAR
H98104102043S0TI ANTEGRA-T PLATE-STERILE 43MM-40MM LENGTH-LUMBAR
H98104102041S0TI ANTEGRA-T PLATE-STERILE 41MM-38MM LENGTH-LUMBAR
H98104102039S0TI ANTEGRA-T PLATE-STERILE 39MM-37MM LENGTH-LUMBAR
H98104102037S0TI ANTEGRA-T PLATE-STERILE 37MM-35MM LENGTH-LUMBAR
H981036611390TRIAL ANTEGRA-T PLATE LUMBAR/53MM
H981036611380TRIAL ANTEGRA-T PLATE LUMBAR/51MM
H981036611370TRIAL ANTEGRA-T PLATE LUMBAR/49MM
H981036611360TRIAL ANTEGRA-T PLATE LUMBAR/47MM
H981036611350TRIAL ANTEGRA-T PLATE LUMBAR/45MM
H981036611340TRIAL ANTEGRA-T PLATE LUMBAR/43MM
H981036611330TRIAL ANTEGRA-T PLATE LUMBAR/41MM
H981036611320TRIAL ANTEGRA-T PLATE LUMBAR/39MM
H981036611310TRIAL ANTEGRA-T PLATE LUMBAR/37MM
H981036611090TRIAL ANTEGRA-T PLATE SACRAL/53MM
H981036611080TRIAL ANTEGRA-T PLATE SACRAL/51MM
H981036611070TRIAL ANTEGRA-T PLATE SACRAL/49MM
H981036611060TRIAL ANTEGRA-T PLATE SACRAL/47MM
H981036611050TRIAL ANTEGRA-T PLATE SACRAL/45MM
H981036611040TRIAL ANTEGRA-T PLATE SACRAL/43MM
H981036611030TRIAL ANTEGRA-T PLATE SACRAL/41MM
H981036611020TRIAL ANTEGRA-T PLATE SACRAL/39MM
H981036611010TRIAL ANTEGRA-T PLATE SACRAL/37MM
H981SD036611250ANTEGRA-T TEMPORARY FIXATION PIN-EXTRA LONG
H981SD031610530ANTEGRA-T AWL-EXTRA LONG
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