SD03231009

GUDID 10886982309112

HANDLE

SYNTHES (U.S.A.) LP

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device ID10886982309112
NIH Device Record Keyf40a7820-92e5-4873-8db2-c749dfce730f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD03.231.009
Catalog NumberSD03231009
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982309112 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


[10886982309112]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-25
Device Publish Date2021-10-15

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

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