201508

GUDID H9802015080

2.4MM CORTEX SCREW SELF-TAPPING 8MM

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 Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable
Primary Device IDH9802015080
NIH Device Record Keya8d552a8-05d9-4393-9415-6e06d99cab91
Commercial Distribution StatusIn Commercial Distribution
Version Model Number201.508
Catalog Number201508
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
GS110887587028538 [Primary]
HIBCCH9802015080 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZLSCREW, FIXATION, INTRAOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

Moist Heat or Steam Sterilization

[H9802015080]

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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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
H679022221200 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/20MM
H679022221220 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/22MM
H679022221240 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/24MM
H679022221260 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/26MM
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