03505041

GUDID H980035050410

1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER

SYNTHES (U.S.A.) LP

Fluted surgical drill bit, reusable
Primary Device IDH980035050410
NIH Device Record Keyba9ea86a-dac8-47d0-817e-cad6540a9c4a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.505.041
Catalog Number03505041
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exempttrue
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
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
GS110887587013497 [Primary]
HIBCCH980035050410 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZJDRIVER, WIRE, AND BONE DRILL, MANUAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


[H980035050410]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-11-22
Device Publish Date2018-09-21

Devices Manufactured by SYNTHES (U.S.A.) LP

10886982297280 - NA2024-09-11 SCHANZ PIN REMOVAL TOOL
H9814871830 - Click'X2024-09-11 7.0MM TI CLICK'X® MONOAXIAL PEDICLE SCREW 90MM THRD LENGTH
H9812982060 - NA2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
H6792042280 - NA2024-07-24 3.5MM SHAFT SCREW 28MM
H6792042320 - NA2024-07-24 3.5MM SHAFT SCREW 32MM
H6792042340 - NA2024-07-24 3.5MM SHAFT SCREW 34MM
H6792042360 - NA2024-07-24 3.5MM SHAFT SCREW 36MM
H6792042380 - NA2024-07-24 3.5MM SHAFT SCREW 38MM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.