311209

GUDID H9803112090

TAP FOR 2.0MM COARSE PITCH SCREWS/HEX COUPLING

SYNTHES (U.S.A.) LP

Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use, non-sterile Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use Bone tap, single-use
Primary Device IDH9803112090
NIH Device Record Key3290f8e5-872b-4697-ad33-8f4706a42248
Commercial Distribution StatusIn Commercial Distribution
Version Model Number311.209
Catalog Number311209
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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587036229 [Primary]
HIBCCH9803112090 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZJDRIVER, WIRE, AND BONE DRILL, MANUAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


[H9803112090]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-30

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

H679022101060 - NA2024-02-27 2.4MM VA LOCKING SCREW STARDRIVE 6MM
H679022221140 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/14MM
H679022221160 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/16MM
H679022221180 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/18MM
H679022221200 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/20MM
H679022221220 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/22MM
H679022221240 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/24MM
H679022221260 - NA2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/26MM

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