ProFlex™
GUDID 00816959020392
INNOVAQUARTZ LLC
General/multiple surgical laser system beam guide, reusable| Primary Device ID | 00816959020392 |
| NIH Device Record Key | 9dfc2698-e17f-407f-84ed-f370acc50728 |
| Commercial Distribution Discontinuation | 2016-09-17 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ProFlex™ |
| Version Model Number | Laser Lithotripsy Fiber |
| 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 | true |
| 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 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816959020392 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142638
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-22 |
On-Brand Devices [ProFlex™]
| 00816959020668 | Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020651 | Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020644 | Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020637 | Maximum Power (J x PPS): 50W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020620 | Maximum Power (J x PPS): 30W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020613 | Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020606 | Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020590 | Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020583 | Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020576 | Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020569 | Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020552 | Maximum Power (J x PPS): 50W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020545 | Maximum Power (J x PPS): 50W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020538 | Maximum Power (J x PPS): 30W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020521 | Maximum Power (J x PPS): 30W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020514 | Maximum Power (J x PPS): 10W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020507 | Maximum Power (J x PPS): 10W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020491 | Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm. |
| 00816959020484 | Laser Lithotripsy Fiber |
| 00816959020477 | Laser Lithotripsy Fiber |
| 00816959020460 | Laser Lithotripsy Fiber |
| 00816959020453 | Laser Lithotripsy Fiber |
| 00816959020446 | Laser Lithotripsy Fiber |
| 00816959020439 | Laser Lithotripsy Fiber |
| 00816959020422 | Laser Lithotripsy Fiber |
| 00816959020415 | Laser Lithotripsy Fiber |
| 00816959020408 | Laser Lithotripsy Fiber |
| 00816959020392 | Laser Lithotripsy Fiber |
| 00816959020385 | Laser Lithotripsy Fiber |
| 00816959020378 | Laser Lithotripsy Fiber |
| 00816959020361 | Laser Lithotripsy Fiber |
| 00816959020354 | Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Prod |
| 00816959020347 | Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Prod |
| 00816959020330 | Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Prod |
| 00816959020323 | Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Prod |
| 00816959020316 | Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Produ |
| 00816959020309 | Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Produ |
| 00816959020293 | Maximum Power (J x PPS): 50W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Produ |
| 00816959020286 | Maximum Power (J x PPS): 50W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Produ |
| 00816959020279 | Maximum Power (J x PPS): 30W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Produc |
| 00816959020262 | Maximum Power (J x PPS): 30W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Produ |
| 00816959020255 | Laser Lithotripsy Fiber |
| 00816959020248 | Laser Lithotripsy Fiber |
| 00816959020231 | Laser Lithotripsy Fiber |
| 00816959020224 | Laser Lithotripsy Fiber |
| 00816959020217 | Laser Lithotripsy Fiber |
| 00816959020200 | Laser Lithotripsy Fiber |
| 00816959020194 | Laser Lithotripsy Fiber |
| 00816959020187 | Laser Lithotripsy Fiber |
| 00816959020170 | Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Prod |
Trademark Results [ProFlex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROFLEX 98837697 not registered Live/Pending |
Gates Corporation 2024-11-05 |
 PROFLEX 98828652 not registered Live/Pending |
KORE OUTDOOR (US) INC. 2024-10-30 |
 PROFLEX 98480005 not registered Live/Pending |
Texas Road Recyclers, LLC 2024-04-02 |
 PROFLEX 98375844 not registered Live/Pending |
John Bean Technologies Corporation 2024-01-25 |
 PROFLEX 98074834 not registered Live/Pending |
Textron Aviation Inc. 2023-07-07 |
 PROFLEX 98003344 not registered Live/Pending |
Proflex Parks, LLC 2023-05-18 |
 PROFLEX 97665722 not registered Live/Pending |
Spigen Korea Co., Ltd. 2022-11-07 |
 PROFLEX 97583519 not registered Live/Pending |
O'Tech Corporation 2022-09-08 |
 PROFLEX 97521130 not registered Live/Pending |
NRDIK LTD 2022-07-26 |
 PROFLEX 97374926 not registered Live/Pending |
LB Marketing, Inc. 2022-04-21 |
 PROFLEX 90875222 not registered Live/Pending |
Textron Aviation Inc. 2021-08-10 |
 PROFLEX 90749887 not registered Live/Pending |
Cain Food Industries, Inc. 2021-06-02 |
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