UreTron Flex Hand Piece

GUDID 00854732006027

UreTron Flex Hand piece for Flex and Semi Flex Probes

MED-SONICS CORPORATION

Ultrasonic lithotripsy system handpiece

• Primary Device ID: 00854732006027
• NIH Device Record Key: a003b640-d23e-4374-81fd-5131e4d9375e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UreTron Flex Hand Piece
• Version Model Number: URT-TF
• Company DUNS: 009836084
• Company Name: MED-SONICS CORPORATION
• Device Count: 1
• DM Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854732006027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160198

FDA Product Code

• FFK: Lithotriptor, Electro-Hydraulic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

[00854732006027]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

Devices Manufactured by MED-SONICS CORPORATION

• 00854732006003 - UreTron Generator: 2018-07-06 UreTron Lithotripter Generator
• 00854732006010 - UreTron Rigid Hand Piece: 2018-07-06 UreTron Rigid Hand Piece
• 00854732006027 - UreTron Flex Hand Piece: 2018-07-06UreTron Flex Hand piece for Flex and Semi Flex Probes
• 00854732006027 - UreTron Flex Hand Piece: 2018-07-06 UreTron Flex Hand piece for Flex and Semi Flex Probes
• 10854732006031 - UreTron Rigid Sterile Probe 3.1 x 370mm: 2018-07-06 UreTron Rigid Sterile Probe 3.1 x 370mm
• 00854732006041 - UreTron Rigid Sterile Probe 3.5 x 370 mm: 2018-07-06 UreTron Rigid Sterile Probe 3.5 x 370 mm
• 00854732006058 - UreTron Rigid Sterile Probe 3.5 x 430mm: 2018-07-06 UreTron Rigid Sterile Probe 3.5 x 430mm
• 00854732006065 - UreTron Rigid Sterile Probe 3.1 x 430 mm: 2018-07-06 UreTron Rigid Sterile Probe 3.1 x 430 mm
• 00854732006072 - UreTron Semi Rigid Sterile Probe 1.9 x 370 mm: 2018-07-06 UreTron Semi Rigid Sterile Probe 1.9 x 370 mm