| Primary Device ID | B064XM11510001 |
| NIH Device Record Key | 5571e6de-27a7-474a-bbbf-d86120164db0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pedicle Screw Instruments Kit |
| Version Model Number | XM-115-1000 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B064XM11510001 [Primary] |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B064XM11510001]
Radiation Sterilization
[B064XM11510001]
Radiation Sterilization
[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
Radiation Sterilization
[B064XM11510001]
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[B064XM11510001]
Radiation Sterilization
[B064XM11510001]
Radiation Sterilization
[B064XM11510001]
Radiation Sterilization
[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
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[B064XM11510001]
Radiation Sterilization
[B064XM11510001]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-19 |
| Device Publish Date | 2022-08-11 |
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| B064XM11510001 - Pedicle Screw Instruments Kit | 2022-08-19 |
| B064XM11510001 - Pedicle Screw Instruments Kit | 2022-08-19 |
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| 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 |