BiomaX

GUDID 00810076560663

BiomaX Bone Graft Putty Plus Chips, 1cc

Surgalign Spine Technologies, Inc.

Bone matrix implant, human-derived
Primary Device ID00810076560663
NIH Device Record Keyb7dc4764-893f-4c13-854b-33b3b009d445
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiomaX
Version Model NumberBMX-0101
Company DUNS014520584
Company NameSurgalign Spine Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com
Phone(844) 894-7752
Emailcustomerservice@surgalign.com

Device Dimensions

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
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 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810076560663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-11-10
Device Publish Date2021-11-02

On-Brand Devices [BiomaX]

00810076560694BiomaX Bone Graft Putty Plus Chips, 10cc
00810076560687BiomaX Bone Graft Putty Plus Chips, 5cc
00810076560670BiomaX Bone Graft Putty Plus Chips, 2.5cc
00810076560663BiomaX Bone Graft Putty Plus Chips, 1cc
00810076560656BiomaX Bone Graft Putty, 10cc
00810076560649BiomaX Bone Graft Putty, 5cc
00810076560380BiomaX Bone Graft Putty, 2.5cc
00810076560007BiomaX Bone Graft Putty, 1cc

Trademark Results [BiomaX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOMAX
BIOMAX
98182475 not registered Live/Pending
Spectrum Solutions L.L.C.
2023-09-15
BIOMAX
BIOMAX
98100749 not registered Live/Pending
Rolf C. Hagen Inc.
2023-07-25
BIOMAX
BIOMAX
97111123 not registered Live/Pending
Platinum LED Lights LLC
2021-11-05
BIOMAX
BIOMAX
90828146 not registered Live/Pending
Surgalign Spine Technologies, Inc.
2021-07-14
BIOMAX
BIOMAX
90781418 not registered Live/Pending
EARTHWISE PACKAGING, INC.
2021-06-18
BIOMAX
BIOMAX
90129622 not registered Live/Pending
The Pond Guy, Inc.
2020-08-21
BIOMAX
BIOMAX
88949996 not registered Live/Pending
Biomax Cosmetics, Inc.
2020-06-05
BIOMAX
BIOMAX
88466592 not registered Live/Pending
WELCOS CO., LTD.
2019-06-10
BIOMAX
BIOMAX
87935022 not registered Live/Pending
AGRIBIO SYSTEMS LLC
2018-05-24
BIOMAX
BIOMAX
87401502 not registered Dead/Abandoned
Abpro Corporation
2017-04-06
BIOMAX
BIOMAX
87324515 5520436 Live/Registered
NATIONWIDE DAIRY INC.
2017-02-03
BIOMAX
BIOMAX
86905027 5111217 Live/Registered
ADITEK DO BRASIL LTDA
2016-02-11

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