05001068

GUDID 07611819168053

IRRIGATION NOZZLE-LONG FOR ELECTRIC PEN DRIVE

SYNTHES (U.S.A.) LP

Surgical irrigation/aspiration tubing set
Primary Device ID07611819168053
NIH Device Record Key33483b0b-2b60-488a-bb78-f41b45f26788
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05.001.068
Catalog Number05001068
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819168053 [Direct Marking]
GS110886982128911 [Primary]
HIBCCH679050010680 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


[07611819168053]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2016-06-30

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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

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