498804

GUDID H6794988040

TI CERCLAGE BUTTON 3.5MM

SYNTHES (U.S.A.) LP

Internal orthopaedic fixation system, cerclage wire/cable, non-sterile
Primary Device IDH6794988040
NIH Device Record Key01ad6a26-8961-4685-8180-621b327039f6
Commercial Distribution StatusIn Commercial Distribution
Version Model Number498.804
Catalog Number498804
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
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
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
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
GS120886982236958 [Primary]
GS180886982236950 [Unit of Use]
HIBCCH6794988040 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTNWASHER, BOLT NUT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6794988040]

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[H6794988040]

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[H6794988040]

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[H6794988040]

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[H6794988040]

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[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

Moist Heat or Steam Sterilization


[H6794988040]

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

H981PDL432F - NA2026-02-09 INLAY PUSHER-MEDIUM
H981PDL434H - NA2026-02-09 INLAY PUSHER-LARGE
07611819995796 - NA2026-02-09 TAMP
07611819943490 - NA2026-02-09 HEAD IMPACTOR
H679E51157P09 - NA2026-02-09 PLASTIC TIP FOR HEAD IMPACTOR
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

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