| Primary Device ID | B064XM24565551 |
| NIH Device Record Key | d6e13ec4-5468-49ee-ae6c-ee5f83a03af2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ø6.5mm x 55mm Pedicle Extended Reduction with Set |
| Version Model Number | XM-245-6555 |
| Company DUNS | 079282130 |
| Company Name | XENCO MEDICAL LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | B064XM24565551 [Primary] |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B064XM24565551]
Radiation Sterilization
[B064XM24565551]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2015-10-30 |
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