400505

GUDID 20887587043934

1.0MM TI MF CORTEX SCREW SELF-TAPPING W/FLUTES 5MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID20887587043934
NIH Device Record Keybf75f8c8-129c-47b8-9ffc-da8d70b328c5
Commercial Distribution StatusIn Commercial Distribution
Version Model Number400.505
Catalog Number400505
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count5
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
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Device Identifiers

Device Issuing AgencyDevice ID
GS120887587043934 [Primary]
GS180887587043936 [Unit of Use]
HIBCCH9804005050 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

Moist Heat or Steam Sterilization


[20887587043934]

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

10886982293060 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 60MM/ XL25
10886982293237 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25
10886982293244 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25
10886982293251 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 34MM/ XL25
10886982293268 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 36MM/ XL25
10886982293275 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 38MM/ XL25
10886982293282 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 40MM/ XL25
10886982293299 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 42MM/ XL25

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