03505003

GUDID 07611819187474

SHAFT FOR 90° SCREWDRIVER

SYNTHES (U.S.A.) LP

Surgical screwdriver, reusable
Primary Device ID07611819187474
NIH Device Record Key542c42f8-7c3a-4657-a6f6-9da699082da0
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.505.003
Catalog Number03505003
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819187474 [Direct Marking]
GS110887587013299 [Primary]
HIBCCH980035050030 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZJDRIVER, WIRE, AND BONE DRILL, MANUAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819187474]

Moist Heat or Steam Sterilization


[07611819187474]

Moist Heat or Steam Sterilization


[07611819187474]

Moist Heat or Steam Sterilization


[07611819187474]

Moist Heat or Steam Sterilization


[07611819187474]

Moist Heat or Steam Sterilization


[07611819187474]

Moist Heat or Steam Sterilization


[07611819187474]

Moist Heat or Steam Sterilization


[07611819187474]

Moist Heat or Steam Sterilization


[07611819187474]

Moist Heat or Steam Sterilization


[07611819187474]

Moist Heat or Steam Sterilization


[07611819187474]

Moist Heat or Steam Sterilization


[07611819187474]

Moist Heat or Steam Sterilization


[07611819187474]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-10-05
Device Publish Date2016-06-30

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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