02130267S

GUDID H67902130267S0

1.5MM VAL FRACTURE PLATE 6 HOLES-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 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 IDH67902130267S0
NIH Device Record Keyb2cf2ee6-e619-4920-981a-14e41a7efba1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number02.130.267S
Catalog Number02130267S
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982045102 [Primary]
HIBCCH67902130267S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


[H67902130267S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-28
Device Publish Date2016-06-30

Devices Manufactured by Synthes GmbH

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
10887587078359 - NA2024-04-16 MANDIBLE BODY REDUCTION HANDLE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.