SD442001

GUDID H679SD4420010

TI WRIST FUSION PLATE-NARROW STD BEND F/2.4 & 2.7MM SCREWS

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 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 IDH679SD4420010
NIH Device Record Keye7b0cf7d-2348-487e-adf8-c19aa84bbe6a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD442.001
Catalog NumberSD442001
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982007377 [Primary]
HIBCCH679SD4420010 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

[H679SD4420010]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-28
Device Publish Date2015-09-14

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