Opus™ BA Strip 71420305

GUDID 00813954025452

Osteoconductive Matrix

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable
Primary Device ID00813954025452
NIH Device Record Key4ed0c6d4-2885-4b8f-a3bc-41e8649d1bc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpus™ BA Strip
Version Model Number71420305
Catalog Number71420305
Company DUNS176262442
Company NameCOLLAGEN MATRIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com
Phone888-298-5700
EmailOSI-CustomerService@Orthofix.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954025452 [Primary]

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-28
Device Publish Date2023-04-20

On-Brand Devices [Opus™ BA Strip]

00813954025483Osteoconductive Matrix
00813954025476Osteoconductive Matrix
00813954025469Osteoconductive Matrix
00813954025452Osteoconductive Matrix

Trademark Results [Opus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPUS
OPUS
98593373 not registered Live/Pending
Applied AI Corporation Limited
2024-06-10
OPUS
OPUS
98516296 not registered Live/Pending
OPUS HERITAGE, L.L.C.
2024-04-24
OPUS
OPUS
98504496 not registered Live/Pending
Pathway Innovations and Technologies, Inc.
2024-04-17
OPUS
OPUS
98460371 not registered Live/Pending
Fleurco Products Inc.
2024-03-21
OPUS
OPUS
98434604 not registered Live/Pending
Quantum-Si Incorporated
2024-03-05
OPUS
OPUS
98281410 not registered Live/Pending
OPUS AMERICAS LLC
2023-11-22
OPUS
OPUS
98281407 not registered Live/Pending
OPUS AMERICAS LLC
2023-11-22
OPUS
OPUS
98066731 not registered Live/Pending
Topgolf Callaway Brands Corp.
2023-06-30
OPUS
OPUS
97928410 not registered Live/Pending
Opus Footwear, Inc.
2023-05-09
OPUS
OPUS
97912513 not registered Live/Pending
Karndean International Limited
2023-04-28
OPUS
OPUS
97841662 not registered Live/Pending
OPUS EQUIPMENT INC.
2023-03-16
OPUS
OPUS
97817580 not registered Live/Pending
Fellow Industries Inc.
2023-03-01

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