| Primary Device ID | 00841668126905 |
| NIH Device Record Key | e5355f5e-2b6d-4c6d-89d4-b93e99de35c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIYAJIMA ADJUSTABLE SPECULUM |
| Version Model Number | AE-1046 |
| Catalog Number | AE-1046 |
| Company DUNS | 085668598 |
| Company Name | KATENA PRODUCTS, INC. |
| 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 | 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 |