Soltive
GUDID 00821925044425
TFL FIBER STRIPPER, 550 MICRON, AUTOCLAVABLE
Gyrus Acmi, Inc.
General/multiple surgical solid-state laser system| Primary Device ID | 00821925044425 |
| NIH Device Record Key | 4f8d3cc9-317f-45e5-92f8-504870b5e1d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Soltive |
| Version Model Number | TFL-AFS 550 |
| Company DUNS | 007198742 |
| Company Name | Gyrus Acmi, Inc. |
| 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821925044425 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183647
FDA Product Code
| GEX | Powered laser surgical instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
[00821925044425]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-31 |
| Device Publish Date | 2020-03-23 |
On-Brand Devices [Soltive]
| 00821925044586 | TFL PREMIUM LASER UNIT - COMPONENT PART |
| 00821925044616 | TFL LASER INTERLOCK CONNECTOR |
| 00821925044609 | TFL LASER VIDEO CABLE ADAPTER |
| 00821925044593 | TTFL STANDARD LASER UNIT - COMPONENT PART |
| 00821925044500 | TFL LASER VIDEO CABLE |
| 00821925044487 | TFL LASER EU STANDARD POWER CORD |
| 00821925044463 | TFL LASER US STANDARD POWER CORD |
| 00821925044449 | TFL FIBER STRIPPER, 940 MICRON, AUTOCLAVABLE |
| 00821925044425 | TFL FIBER STRIPPER, 550 MICRON, AUTOCLAVABLE |
| 00821925044401 | TFL FIBER STRIPPER, 365 MICRON, AUTOCLAVABLE |
| 00821925044388 | TFL FIBER STRIPPER, 200 MICRON, AUTOCLAVABLE |
| 00821925044340 | TFL FIBER CLEAVER |
| 00821925044326 | TFL LASER BLAST SHIELD |
| 00821925044302 | TFL LASER WARNING SIGN |
| 00821925044272 | TFL Laser Footswitch - Wireless |
| 00821925044258 | TFL Laser Footswitch - Wired |
| 00821925044135 | TFL STANDARD LASER SYSTEM |
| 00821925044111 | TFL PREMIUM LASER SYSTEM |
| 00821925044036 | 550 Micron TFL Single Use Fiber, 5/Box |
| 00821925044098 | SOLTIVE SUPERPULSED LASER FIBER (5/Pk) |
| 00821925043879 | SOLTIVE SuperPulsed Laser Fiber 150 Micron |
| 00821925044074 | SOLTIVE SuperPulsed Laser Fiber 940 Micron |
| 00821925043992 | SOLTIVE SuperPulsed Laser Fiber 365 Micron |
| 00821925043978 | SOLTIVE SuperPulsed Laser Fiber 200 Micron |
| 00821925043930 | SOLTIVE SuperPulsed Laser Fiber 200 Micron |
| 00821925043916 | SOLTIVE SuperPulsed Laser Fiber 150 Micron |
Trademark Results [Soltive]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLTIVE 88270800 not registered Live/Pending |
Olympus Corporation 2019-01-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.