BEAST PLUS
GUDID 00889795113283
BEAST PLUS Putty, 5.0cc
X-SPINE SYSTEMS, INC.
Bone matrix implant, human-derived| Primary Device ID | 00889795113283 |
| NIH Device Record Key | 11842e5b-f37e-47a5-ae88-a1c70b54b330 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BEAST PLUS |
| Version Model Number | P01-DBM-3050 |
| Company DUNS | 610042587 |
| Company Name | X-SPINE SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | true |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| CS@xtantmedical.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889795113283 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150621
FDA Product Code
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-06 |
| Device Publish Date | 2021-04-28 |
On-Brand Devices [BEAST PLUS]
| 00889795113290 | BEAST PLUS Putty, 10.0cc |
| 00889795113283 | BEAST PLUS Putty, 5.0cc |
| 00889795113276 | BEAST PLUS Putty, 2.5cc |
Trademark Results [BEAST PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BEAST PLUS 90730134 not registered Live/Pending |
Paragon 28, Inc. 2021-05-24 |
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