03315700

GUDID 07612334121059

1.0MM/1.3MM SCRWDRIVER BLADE FOR RAISED HD SCRW/HEX CO/86MM

SYNTHES (U.S.A.) LP

Surgical screwdriver, reusable
Primary Device ID07612334121059
NIH Device Record Key86cacb30-4062-4237-81ef-052e938a4b63
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.315.700
Catalog Number03315700
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107612334121059 [Direct Marking]
GS110887587073590 [Primary]

FDA Product Code

GXLSCREWDRIVER, SKULLPLATE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


[07612334121059]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-23
Device Publish Date2019-12-13

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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