| Primary Device ID | 07290018446126 |
| NIH Device Record Key | 5c7575a4-89c8-4cf4-9053-9d228ae28216 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N9 speculum |
| Version Model Number | N/A |
| Catalog Number | MHD-100-02-033 |
| Company DUNS | 532283903 |
| Company Name | NONAGON LTD |
| Device Count | 27 |
| 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 | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07290018446126 [Unit of Use] |
| GS1 | 27290018446120 [Primary] |
| FXG | Specula Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-21 |
| Device Publish Date | 2021-09-13 |
| 17290018446154 - Nonagon N9+ | 2022-10-06 |
| 27290018446151 - Nonagon N9+ SmartExam | 2022-10-06 |
| 07290018446126 - N9 speculum | 2021-09-21ENT ear speculum for Nonagon N9 device |
| 07290018446126 - N9 speculum | 2021-09-21 ENT ear speculum for Nonagon N9 device |
| 07290018446102 - Nonagon | 2021-06-03 The Nonagon N9 device is a home use device. The device is comprised of a handheld unit that connects with a smartphone and a ded |