| Primary Device ID | 00810633020708 |
| NIH Device Record Key | 00f0cb42-373f-4082-98ae-36f13d27ec33 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BoneHog |
| Version Model Number | LM-08 |
| Company DUNS | 792619009 |
| Company Name | Biomedical Enterprises, 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 | 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 |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810633020708 [Primary] |
| GEY | Motor, Surgical Instrument, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-05-07 |
| Device Publish Date | 2015-10-24 |
| 00810633020715 | Excalibur BGS(bone grafting system) 6mm collection chamber |
| 00810633020708 | BoneHog 8mm Collection Chamber |
| 00810633020692 | BoneHog 6mm Collection Chamber |