| Primary Device ID | B064MPE010101 |
| NIH Device Record Key | d3016a81-54bc-415a-9a8c-d2956ac741e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Saratoga Cervical Brace |
| Version Model Number | MPE01010 |
| Company DUNS | 079282130 |
| Company Name | XENCO MEDICAL 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 | true |
| 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 | B064MPE010101 [Primary] |
| IQK | Orthosis, Cervical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-15 |
| Device Publish Date | 2023-08-07 |
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| B064MPE010101 - Saratoga Cervical Brace | 2023-08-15 |
| B064MPE010101 - Saratoga Cervical Brace | 2023-08-15 |
| B064MPE010401 - Tahiti Lumbar Brace | 2023-08-15 |
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| B064XM12723451 - 27mm x 12mm TLIF Trial Kit 12, 13, 14, 15 mm Heights | 2020-04-06 27mm x 12mm TLIF Trials: 12, 13, 14, 15 mm Heights |
| B064XM12789011 - 27mm x 12mm TLIF Trial Kit 8, 9, 10, 11 mm Heights | 2020-04-06 |
| B064XM12823451 - 28mm x 11mm Oblique Trials 12, 13, 14, 15 mm Heights | 2020-04-06 28mm x 11mm Oblique Trial Kit 12, 13, 14, 15 mm Heights |