BioSet® 005800

GUDID 00854095006313

DBM Paste

Rti Surgical, Inc.

Bone matrix implant, human-derived

Primary Device ID	00854095006313
NIH Device Record Key	dc0f69ef-6372-4afa-89b0-cd88eaf9f81e
Commercial Distribution Status	In Commercial Distribution
Brand Name	BioSet®
Version Model Number	005800
Catalog Number	005800
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	00854095006313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K043420

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®]

00854095006948	IC Moldable Strip, 90mm (2 each)
00854095006931	IC Moldable Strip, 50mm (2 each)
00854095006924	IC, RT Allograft Paste, 20cc
00854095006917	IC, RT Allograft Paste, 10cc
00854095006900	IC, RT Allograft Paste, 5cc
00854095006894	IC, RT Allograft Paste, 2cc
00854095006849	RT Allograft Paste, Syringe, 10cc
00854095006832	RT Allograft Paste, Syringe, 5cc
00854095006825	RT Allograft Paste, Syringe, 1cc
00854095006818	RT Allograft Paste, Syringe, 0.5cc
00854095006733	DBM Paste
00854095006726	DBM Paste
00854095006719	DBM Paste
00854095006702	DBM Paste
00854095006696	DBM Paste
00854095006689	DBM Paste
00854095006672	DBM Paste
00854095006665	DBM Paste
00854095006658	DBM Paste
00854095006641	DBM Paste
00854095006634	DBM Paste
00854095006627	DBM Paste
00854095006610	DBM Paste
00854095006603	DBM Paste
00854095006498	DBM Paste
00854095006481	DBM Paste
00854095006474	DBM Paste
00854095006467	DBM Paste
00854095006450	DBM Paste
00854095006443	DBM Paste
00854095006436	DBM Paste
00854095006429	DBM Paste
00854095006412	DBM Paste
00854095006405	DBM Paste
00854095006399	DBM Paste
00854095006382	DBM Paste
00854095006375	DBM Paste
00854095006368	DBM Paste
00854095006351	DBM Paste
00854095006344	DBM Paste
00854095006337	DBM Paste
00854095006320	DBM Paste
00854095006313	DBM Paste
00854095006306	DBM Paste
00854095006290	DBM Paste
00854095006283	DBM Paste
00854095006276	DBM Paste

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