04214018

GUDID H679042140180

1.5MM TI LOCKING SCR SLF-TPNG WITH T4 STARDRIVE RECESS 18MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)
Primary Device IDH679042140180
NIH Device Record Keyb0541d02-d08d-41d3-80f2-27dca07d5969
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.214.018
Catalog Number04214018
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
GS110886982120755 [Primary]
HIBCCH679042140180 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

Moist Heat or Steam Sterilization

[H679042140180]

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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10886982344434 - NA2024-03-21 PROTECTION SLV F/NAILS/Ø8-13MM RIGID/TIBIAL FIXTN/LNG/STER
10886982345745 - NA2024-03-21 PROTECTION SLV F/NAILS/Ø8-11MM RIGID/LONG/STERILE
10886982345752 - NA2024-03-21 PROTECTION SLV F/NAILS/Ø8-13MM RIGID/LONG/STERILE
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