04130254

GUDID H679041302540

1.5MM TI VAL PHALANGEAL BASE PLATE-2 HOLES HD-6 HOLES SHAFT

Synthes GmbH

Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable
Primary Device IDH679041302540
NIH Device Record Key849b91d5-6b99-4d0e-b7fa-75e7a4db9fcf
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.130.254
Catalog Number04130254
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982112941 [Primary]
HIBCCH679041302540 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


[H679041302540]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-29
Device Publish Date2015-09-14

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10886982344250 - NA2024-05-13 HOOK - 10MM UPRIGHT REDUCTION CLAMP
10886982346940 - NA2024-05-09 60MM DEPTH PROBE FOR XL25 SCREWS
10886982346933 - NA2024-05-08 EXTENDED MULTI HOLE WIRE GUIDE FOR RFNA
10886982346957 - NA2024-05-08 FNS ANGLED GUIDE 130° W/ WIDER BASE

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