04130253S

GUDID H67904130253S0

1.5MM TI VAL Y-PLATE 3H HEAD-7H SHAFT-STERILE

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 IDH67904130253S0
NIH Device Record Keyd531ffc2-9a06-48d1-841a-9bbcccad63cb
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.130.253S
Catalog Number04130253S
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 Datetrue
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
GS110886982112934 [Primary]
HIBCCH67904130253S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

[H67904130253S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-29
Device Publish Date2016-06-30

Devices Manufactured by Synthes GmbH

10887587078366 - NA2024-05-22 BONE PUSHER
10886982344229 - NA2024-05-13 FOOT - 10MM UPRIGHT REDUCTION CLAMP
10886982344236 - NA2024-05-13 FOOT - 4MM UPRIGHT REDUCTION CLAMP
10886982344243 - NA2024-05-13 HOOK - 4MM UPRIGHT REDUCTION CLAMP
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.