04170640

GUDID 10886982304513

6.0MM TI SELF-DRILLING SCHANZ SCREW 40MM THRD/175MM

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 ID10886982304513
NIH Device Record Keyb15c60d7-2a38-4f20-9c36-f5156daeb1e2
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.170.640
Catalog Number04170640
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS110886982304513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSNSoftware for diagnosis/treatment

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

[10886982304513]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-15
Device Publish Date2022-02-07

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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