04305003

GUDID H980043050030

2.5MM/4.0MM TI SCHANZ SCREW BLUNT TIP 50MM

SYNTHES (U.S.A.) LP

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 IDH980043050030
NIH Device Record Keydd775986-3d1f-4593-ae3f-044ad358cc9e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.305.003
Catalog Number04305003
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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
GS110887587015095 [Primary]
HIBCCH980043050030 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

[H980043050030]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-14

Devices Manufactured by SYNTHES (U.S.A.) LP

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10886982311542 - NA2024-06-06 INNER TUBE ASSEMBLY K-WIRE CUTTER
10886982311559 - NA2024-06-06 OUTER TUBE ASSEMBLY K-WIRE CUTTER
H679022101060 - NA2024-02-27 2.4MM VA LOCKING SCREW STARDRIVE 6MM
H679022221140 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/14MM
H679022221160 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/16MM
H679022221180 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/18MM
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