VERASENSE SYK-TRCR 04

GUDID 00816818020334

ORTHOSENSOR INC

Arthroplasty force sensor
Primary Device ID00816818020334
NIH Device Record Keycadb25ed-50b7-419f-98ab-5ed604f4e3f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameVERASENSE
Version Model NumberVERASENSE for Stryker Triathlon size 4
Catalog NumberSYK-TRCR 04
Company DUNS005788130
Company NameORTHOSENSOR 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 Numbertrue
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 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 36 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 47 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816818020334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONNIntraoperative Orthopedic Joint Assessment Aid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-21
Device Publish Date2016-09-23

On-Brand Devices [VERASENSE]

00816818021461VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Ri
00816818021454VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Le
00816818021447VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Ri
00816818021430VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Le
00816818021423VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Rig
00816818021416VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Lef
00816818021409VERASENSE for Zimmer NexGen PS E-F/5-6
00816818021393VERASENSE for Zimmer NexGen PS E-F/3-4
00816818021386VERASENSE for Zimmer NexGen PS C-D/3-4
00816818021379VERASENSE for Zimmer NexGen CR C-H/7-10
00816818021362VERASENSE for Zimmer NexGen CR C-H/5-6
00816818021355VERASENSE for Zimmer NexGen CR C-H/3-4
00816818021348VERASENSE for Stryker Triathlon size 7
00816818021331VERASENSE for Stryker Triathlon size 6
00816818021324VERASENSE for Stryker Triathlon size 5
00816818021317VERASENSE for Stryker Triathlon size 4
00816818021300VERASENSE for Stryker Triathlon size 3
00816818021294VERASENSE for Stryker Triathlon size 2
00816818021287VERASENSE for Smith & Nephew Legion CR size 7-8
00816818021270VERASENSE for Smith & Nephew Legion CR size 5-6
00816818021263VERASENSE for Smith & Nephew Legion CR size 3-4
00816818021256VERASENSE for Smith & Nephew Legion CR size 1-2
00816818021249VERASENSE for Smith & Nephew Legion PS size 7-8
00816818021232VERASENSE for Smith & Nephew Legion PS size 5-6
00816818021225VERASENSE for Smith & Nephew Legion PS size 3-4
00816818021218VERASENSE for Smith & Nephew Legion PS size 1-2
00816818021201VERASENSE for Smith & Nephew Journey II CR 7-8 Rig
00816818021195VERASENSE for Smith & Nephew Journey II CR 7-8 Lef
00816818021188VERASENSE for Smith & Nephew Journey II CR 5-6 Rig
00816818021171VERASENSE for Smith & Nephew Journey II CR 5-6 Lef
00816818021164VERASENSE for Smith & Nephew Journey II CR 3-4 Rig
00816818021157VERASENSE for Smith & Nephew Journey II CR 3-4 Lef
00816818021140VERASENSE for Smith & Nephew Journey II CR 1-2 Rig
00816818021133VERASENSE for Smith & Nephew Journey II CR 1-2 Lef
00816818021126VERASENSE for Smith & Nephew Journey II BCS 7-8 Ri
00816818021119VERASENSE for Smith & Nephew Journey II BCS 7-8 Le
00816818021102VERASENSE for Smith & Nephew Journey II BCS 5-6 Ri
00816818021096VERASENSE for Smith & Nephew Journey II BCS 5-6 Le
00816818021089VERASENSE for Smith & Nephew Journey II BCS 3-4 Ri
00816818021072VERASENSE for Smith & Nephew Journey II BCS 3-4 Le
00816818021065VERASENSE for Smith & Nephew Journey II BCS 1-2 Ri
00816818021058VERASENSE for Smith & Nephew Journey II BCS 1-2 Le
00816818021041VERASENSE for Biomet Vanguard PS size 79/83
00816818021034VERASENSE for Biomet Vanguard PS size 71/75
00816818021027VERASENSE for Biomet Vanguard PS size 63/67
00816818021010VERASENSE for Biomet Vanguard CR size 79/83
00816818021003VERASENSE for Biomet Vanguard CR size 71/75
00816818020990VERASENSE for Biomet Vanguard CR size 63/67
00816818020983VERASENSE for Zimmer NexGen PS E-F/5-6
00816818020976VERASENSE for Zimmer NexGen PS E-F/3-4

Trademark Results [VERASENSE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VERASENSE
VERASENSE
85882184 not registered Live/Pending
Orthosensor, Inc.
2013-03-21

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