04633401

GUDID H981046334010

TI SNAP-ON OPEN PARALLEL CONNECTOR 5.5MM/6.0MM

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDH981046334010
NIH Device Record Key9f2e15d1-e648-4837-bbd5-23722954c581
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.633.401
Catalog Number04633401
Company DUNS486711679
Company NameSynthes GmbH
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 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
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
GS110705034746753 [Primary]
HIBCCH981046334010 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


[H981046334010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-26
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

07612334226747 - NA2025-07-31 LID 2/3 SIZE STAINLESS STEEL
07612334227980 - NA2025-07-31 TRAY FOR OPERACE, 1 FROM 2
07612334228352 - NA2025-07-31 TRAY FOR OPERACE, 2 FROM 2
10886982348982 - NA2025-07-24 Ø12.8MM HOLLOW REAMER
10886982349835 - NA2025-07-24 WRENCH / 11MM SLOTTED SOCKET
10886982350121 - NA2025-07-24 FEMORAL GONIOMETER
10886982350152 - NA2025-07-24 5TH MET WIRE GUIDE
10886982350428 - NA2025-07-24 TENS BENDING EXTRACTOR

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.