SonoSurg GE Straight Sheath

GUDID 14953170183000

OLYMPUS MEDICAL SYSTEMS CORP.

Soft-tissue ultrasonic surgical system

Primary Device ID	14953170183000
NIH Device Record Key	a8c8f149-3da5-4cbe-ac19-9b15ed5cdc4e
Commercial Distribution Status	In Commercial Distribution
Brand Name	SonoSurg GE Straight Sheath
Version Model Number	T3310
Company DUNS	711789789
Company Name	OLYMPUS MEDICAL SYSTEMS CORP.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170183003 [Primary]
GS1	14953170183000 [Package] Contains: 04953170183003 Package: [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K032066
Premarket Notification: K050885

FDA Product Code

LFL	Instrument, ultrasonic surgical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

[14953170183000]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2018-10-08
Device Publish Date	2017-10-06

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04953170464973 - THUNDERBEAT 5 mm, 35 cm, Inline Grip	2024-09-17
04953170464980 - THUNDERBEAT 5 mm, 45 cm, Inline Grip	2024-09-17
14953170464994 - SONICBEAT 5 mm, 10 cm, Inline Grip	2024-09-17
14953170465021 - SONICBEAT 5 mm, 35 cm, Pistol Grip	2024-09-17
14953170465045 - SONICBEAT 5 mm, 45 cm, Pistol Grip	2024-09-17
14953170409971 - Single Use Aspiration Needle NA-U401SX	2024-07-11

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