ProFlex SU550PF
GUDID 00816959020729
INNOVAQUARTZ LLC
General/multiple surgical laser system beam guide, reusable| Primary Device ID | 00816959020729 |
| NIH Device Record Key | 75308292-d67b-4101-9779-0557e75da9e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProFlex |
| Version Model Number | SU550PF |
| Catalog Number | SU550PF |
| 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 | 00816959020729 [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 | 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 |
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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