BioHorizons

GUDID 00847236016043

IntraSpin System 220V, Procedure Pack

BIOHORIZONS IMPLANT SYSTEMS, INC

Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system
Primary Device ID00847236016043
NIH Device Record Keycbbc114f-1b76-44f8-b50e-ff8ed4685cb1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioHorizons
Version Model NumberLPRF220
Company DUNS967279910
Company NameBIOHORIZONS IMPLANT SYSTEMS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100847236016043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-13
Device Publish Date2021-04-05

On-Brand Devices [BioHorizons]

00847236014124Prosthetic Screw, Multi-unit, Small (pack of 5)
00847236013691Multi-unit Direct Pick-up Coping
008472360136533.0mm Deep Bone Profiler
008472360136463.5mm Deep Bone Profiler
008472360136394.5mm Deep Bone Profiler
008472360136225.7mm Deep Bone Profiler
00847236013615Prosthetic Screw, Multi-unit, Regular
008472360136083.0mm Snap Scan Body, 8mm
008472360135923.0mm Snap Scan Body, 11mm
008472360135853.5mm Snap Scan Body, 8mm
008472360135783.5mm Snap Scan Body, 11mm
008472360135614.5mm Snap Scan Body, 8mm
008472360135544.5mm Snap Scan Body, 11mm
008472360135475.7mm Snap Scan Body, 8mm
008472360135305.7mm Snap Scan Body, 11mm
008472360135233.0mm Straight Contour Abutment (3mm buccal height)
008472360135163.0mm Straight Contour Abutment
008472360135093.0mm Dual Purpose Contour Abutment
008472360134933.0mm Angled Contour Abutment
008472360134863.5mm Straight Contour Abutment (3mm buccal height)
008472360134793.5mm Straight Contour Abutment
008472360134623.5mm Dual Purpose Contour Abutment
008472360134553.5mm Angled Contour Abutment
008472360134484.5mm Straight Contour Abutment (3mm buccal height)
008472360134314.5mm Straight Contour Abutment
008472360134244.5mm Dual Purpose Contour Abutment
008472360134174.5mm Angled Contour Abutment
008472360134005.7mm Straight Contour Abutment
008472360133945.7mm Dual Purpose Contour Abutment
008472360133875.7mm Angled Contour Abutment
008472360133705.7mm Try-in Multi-unit Abutment, 30-degree
008472360133635.7mm Try-in Multi-unit Abutment, 17-degree
00847236013356Precision Angled Driver, 4mm Square, Extra Long
00847236013349Precision Angled Driver, 4mm Square, Long
00847236013332Precision Angled Driver, Manual, Long
00847236013325Precision Angled Driver, Handpiece, Long
00847236013318ODSecure Xtend Lab Process Insert (Black) (4 pack)
00847236013288Single-stage 3.5mm Hybrid Abutment Base, Hexed
00847236013271Single-stage 4.5mm Hybrid Abutment Base, Hexed
00847236013264Single-stage 5.7mm Hybrid Abutment Base, Hexed
008472360132403.0mm Hybrid Abutment Base, 2mm Collar Height
008472360132333.5mm Hybrid Abutment Base, 2mm Collar Height
008472360132264.5mm Hybrid Abutment Base, 2mm Collar Height
008472360132195.7mm Hybrid Abutment Base, 2mm Collar Height
008472360132025.7mm Multi-unit Abutment, 30-degree, 4mm Collar
008472360131965.7mm Multi-unit Abutment, 30-degree, 3mm Collar
008472360131895.7mm Multi-unit Abutment, 17-degree, 2.25mm Collar
00847236013172Tapered Offset Site Dilator Kit
008472360131653.5mm Hybridge XD Kit
00847236013134Tack Driver Tip, Manual

Trademark Results [BioHorizons]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOHORIZONS
BIOHORIZONS
76452693 2794090 Live/Registered
Evollution IP Holdings, Inc.
2002-09-25
BIOHORIZONS
BIOHORIZONS
76452692 2794089 Live/Registered
Evoluution IP Holdings, Inc.
2002-09-25
BIOHORIZONS
BIOHORIZONS
75975064 1998825 Dead/Cancelled
BioHorizons, Inc.
1993-10-06
BIOHORIZONS
BIOHORIZONS
74735451 not registered Dead/Abandoned
BioHorizons, Inc.
1995-09-28
BIOHORIZONS
BIOHORIZONS
74735450 2017329 Dead/Cancelled
BioHorizons, Inc.
1995-09-28
BIOHORIZONS
BIOHORIZONS
74734382 not registered Dead/Abandoned
BioHorizons, Inc.
1995-09-26
BIOHORIZONS
BIOHORIZONS
74734381 not registered Dead/Abandoned
BioHorizons, Inc.
1995-09-26
BIOHORIZONS
BIOHORIZONS
74734343 not registered Dead/Abandoned
BioHorizons, Inc.
1995-09-26
BIOHORIZONS
BIOHORIZONS
74734342 2017325 Dead/Cancelled
BioHorizons, Inc.
1995-09-26
BIOHORIZONS
BIOHORIZONS
74734341 2021912 Dead/Cancelled
BioHorizons, Inc.
1995-09-26
BIOHORIZONS
BIOHORIZONS
74444510 1893788 Dead/Cancelled
BioHorizons, Inc.
1993-10-06
BIOHORIZONS
BIOHORIZONS
74444509 not registered Dead/Abandoned
BioHorizons, Inc.
1993-10-06

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