| Primary Device ID | 17290114352007 |
| NIH Device Record Key | 82b3c0c0-cdbc-4631-9ed5-ca185007a7ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spotter Device Set |
| Version Model Number | SPR |
| Company DUNS | 532219235 |
| Company Name | FORUM ENGINEERING TECHNOLOGIES (96) LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 17290114352007 [Primary] |
| LNF | System, Hyperthermia, Manual Control |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
[17290114352007]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-26 |
| Device Publish Date | 2024-09-18 |
| 07290114352000 - Spotter Device (without accessories) | 2024-09-26 Spotter Device (without accessories) |
| 17290114352007 - Spotter Device Set | 2024-09-26Spotter Device set |
| 17290114352007 - Spotter Device Set | 2024-09-26 Spotter Device set |
| 17290114352106 - Spotter Demo set | 2024-09-26 Spotter Demo set |
| 17290114352205 - Spotter Probes - Package of 2 | 2024-09-26 Spotter Probes - Package of 2 |
| 17290114352304 - Spotter Sensors - Package of 5 | 2024-09-26 Spotter Sensors - Package of 5 |
| 17290114352908 - Sensors | 2024-09-26 Sensors |
| 07290114350006 - NovApex | 2024-01-01 NovApex N-31 Apex Locator |
| 07290114351003 - Bingo-Pro | 2024-01-01 Bingo-Pro Apex Locator |