ProFlex TRU365PF

GUDID 00816959020927

INNOVAQUARTZ LLC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00816959020927
• NIH Device Record Key: bd21e17d-d998-423b-b8a2-59cf948d2ce5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProFlex
• Version Model Number: TRU365PF
• Catalog Number: TRU365PF
• Company DUNS: 079295103
• Company Name: INNOVAQUARTZ LLC
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816959020927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142638

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959020927]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-01

On-Brand Devices [ProFlex]

• 00816959020941: TRU1000PF
• 00816959020934: TRU550PF
• 00816959020927: TRU365PF
• 00816959020910: TRU273PF
• 00816959020903: TRU200PF
• 00816959020897: RU1000PF
• 00816959020880: RU550PF
• 00816959020873: RU365PF
• 00816959020866: LRU273PF
• 00816959020859: DRU273PF
• 00816959020842: LRU200PF
• 00816959020835: DRU200PF
• 00816959020828: DSU273PT
• 00816959020811: DSU200PT
• 00816959020804: LSU273PT
• 00816959020798: LSU200PT
• 00816959020781: TSU1000PF
• 00816959020774: TSU550PF
• 00816959020767: TSU365PF
• 00816959020750: TSU273PF
• 00816959020743: TSU200PF
• 00816959020736: SU1000PF
• 00816959020729: SU550PF
• 00816959020712: SU365PF
• 00816959020705: LSU273PF
• 00816959020699: DSU273PF
• 00816959020682: LSU200PF
• 00816959020675: ProFlex® 200 Laser Lithotripsy Fiber Single-Use