| Primary Device ID | G04360204G0 |
| NIH Device Record Key | 6d5cbb7f-2d3b-4173-bbc1-0e20e9e7ce61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEIZ |
| Version Model Number | 6.02.04.G |
| Catalog Number | 6.02.04.G |
| Company DUNS | 123551586 |
| Company Name | Bear-Ent, LLC |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
|---|---|
| HIBCC | G04360204G0 [Primary] |
| EPY | Speculum, Ent |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G04360204G0]
Moist Heat or Steam Sterilization
[G04360204G0]
Moist Heat or Steam Sterilization
[G04360204G0]
Moist Heat or Steam Sterilization
[G04360204G0]
Moist Heat or Steam Sterilization
[G04360204G0]
Moist Heat or Steam Sterilization
[G04360204G0]
Moist Heat or Steam Sterilization
[G04360204G0]
Moist Heat or Steam Sterilization
[G04360204G0]
Moist Heat or Steam Sterilization
[G04360204G0]
Moist Heat or Steam Sterilization
[G04360204G0]
Moist Heat or Steam Sterilization
[G04360204G0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-13 |
| Device Publish Date | 2026-03-05 |
| G04360204G0 | Hartmann Ear Specula, 8.0mm |
| G04360203G0 | Hartmann Ear Specula, 6.5mm |
| G04360202G0 | Hartmann Ear Specula, 5.0mm |
| G04360201G0 | Hartmann Ear Specula, 3.5mm |
| G04360200G0 | Hartmann Ear Specula, 2.0mm |