| Primary Device ID | B064XM34235791 |
| NIH Device Record Key | 339ca39b-af45-44f8-b071-4715c83e4790 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 34mm x 28mm x 20° ALIF Rasp Kit 13, 15, 17mm Heights |
| Version Model Number | XM-342-3579 |
| 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 | B064XM34235791 [Primary] |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
[B064XM34235791]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2015-10-28 |