03505054

GUDID H980035050540

1.8MM DIA DRILL BIT W/8MM STOP 15MM LENGTH F/90° SCREWDRIVER

SYNTHES (U.S.A.) LP

Fluted surgical drill bit, reusable
Primary Device IDH980035050540
NIH Device Record Key41a0e3f8-eb25-4060-842d-4793bcfc5801
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.505.054
Catalog Number03505054
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
GS110887587013534 [Primary]
HIBCCH980035050540 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZJDRIVER, WIRE, AND BONE DRILL, MANUAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

Moist Heat or Steam Sterilization


[H980035050540]

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

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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

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