| Primary Device ID | B829991 |
| NIH Device Record Key | 099b3792-ac01-42ae-aadf-0a0f59cb39d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eclipse 350 |
| Version Model Number | Eclipse 350 |
| Catalog Number | 99 |
| Company DUNS | 253873905 |
| Company Name | PDG Product Design Group 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B829991 [Primary] |
| IOR | Wheelchair, Mechanical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-15 |
| Device Publish Date | 2023-06-07 |
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| B829971 - Luna | 2023-06-15 |
| B829981 - Astrotilt | 2023-06-15 |
| B829991 - Eclipse 350 | 2023-06-15 |
| B829991 - Eclipse 350 | 2023-06-15 |
| B829271 - Bentley Manual Tilt Wheelchair | 2022-09-09 |
| B829101 - Bentley Manual Tilt Wheelchair | 2020-10-06 |
| B829111 - Eclipse Bariatric Manual Wheelchair | 2020-10-06 |
| B829121 - Stellar Manual Tilt Wheelchair | 2020-10-06 |