BioSet®
GUDID 00854095006696
DBM Paste
Rti Surgical, Inc.
Bone matrix implant, human-derived| Primary Device ID | 00854095006696 |
| NIH Device Record Key | 2fd433d4-1d9f-4fc1-8e5f-528eb8e5da73 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioSet® |
| Version Model Number | 807830 |
| Company DUNS | 014520584 |
| Company Name | Rti Surgical, 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 | true |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -39 Degrees Celsius and -20 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854095006696 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043421
FDA Product Code
| MQV | FILLER, BONE VOID, CALCIUM COMPOUND |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-11-06 |
On-Brand Devices [BioSet®]
Trademark Results [BioSet]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOSET 98779027 not registered Live/Pending |
Dongguan Juxin Technology Development Co., Ltd. 2024-09-30 |
 BIOSET 98359712 not registered Live/Pending |
Ferring B.V. 2024-01-16 |
 BIOSET 88767823 not registered Live/Pending |
Ferring B.V. 2020-01-21 |
 BIOSET 78783223 3754781 Live/Registered |
FERRING B.V. 2005-12-30 |
 BIOSET 78701644 3514116 Live/Registered |
RTI SURGICAL, INC. 2005-08-26 |
 BIOSET 75900908 2981243 Live/Registered |
THE BIOSET GROUP, LLC 2000-01-21 |
 BIOSET 75825768 2383251 Dead/Cancelled |
Bioset, Inc. 1999-10-18 |
 BIOSET 75355066 not registered Dead/Abandoned |
BIOSET, INC. 1997-09-11 |
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