05000008

GUDID 07611819890084

HAND PIECE FOR BATTERY POWERED DRIVER

SYNTHES (U.S.A.) LP

Multi-purpose surgical power tool system, rechargeable battery-powered
Primary Device ID07611819890084
NIH Device Record Key11798eb2-b9df-40a2-99d9-ad4857a28eca
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05.000.008
Catalog Number05000008
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
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
GS107611819890084 [Direct Marking]
GS110887587024585 [Primary]
HIBCCH980050000080 [Secondary]

FDA Product Code

GXLSCREWDRIVER, SKULLPLATE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


[07611819890084]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-22
Device Publish Date2017-05-09

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.