FDA.reportPublic FDA data

AVRA BACK SECTION 3IN SKYTRON 6500, 6600

Primary DI
00842430110320
Brand
AVRA BACK SECTION 3IN SKYTRON 6500, 6600
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
69413AVB
Catalog number
69413AVB
Published
2021-06-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JFCSystem, Pressure Measurement, Intermittent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFCSystem, Pressure Measurement, IntermittentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430110320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430110320008424301103208424301103200842430110320

GMDN Terms#

Term, Definition table
TermDefinition
Operating table mattress, pressure-sensingAn electrically-powered cushioned mattress with pressure-sensing properties designed to be placed on top of an operating table to serve as the surface upon which the patient is placed, and to map the patient’s body pressure distribution on its surface during a surgical procedure; the gathered data is transmitted to a pressure monitoring hub/tablet for analysis and display. The device is constructed with a pressure-sensitive fabric and is available in pads of different lengths. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure75 KiloPascal105 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-777-4674CustServ@mizuhosi.com
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags#

DUNS number
084527241
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842430106989BUTTOCKS STRAP W/ VELCRO6977-7396977-7392018-12-07
00842430109027Avra Smart Hub Powered by BodiTrak2872-102872-102021-06-14
00842430110283AVRA HEAD SECTION 3IN STERIS 3080, 308569403AVH69403AVH2021-06-14
00842430110290AVRA BACK SECTION 3IN STERIS 3080, 308569403AVB69403AVB2021-06-14
00842430110306AVRA FOOT SECTION, 3IN, STERIS 3080, 308569403AVF69403AVF2021-06-14
00842430110641AVRA 3-PC SET 3IN STERIS 3080 308569403AVS69403AVS2021-06-14
00842430111266AVRA WIRELESS TABLET DISPLAY2872-402872-402021-06-14
00842430112553LATERAL SUPPORT PAD ASSEMBLY5338-1005338-1002021-02-01
00842430101663TABLE, ProFx, REFURBISHED6850R6850R2020-09-09
00842430101977TABLE, INSITE, REFURBISHED6844R6844R2020-09-09
00842430115097SLING, REHAB SHOULDER, ABDUCTION8678672020-09-03
00842430112119IMMOBILIZER, SHOULDER, UNIVESAL,W/ STRAP146S146S2020-07-27
00842430100031Allegro Table Refurbished 120V, 60HZ6800R6800R2016-09-15
00842430104022ALUMINUM SIDE RAIL SOCKET539453942018-04-18
00842430104404PIVOTING ARM BOARD W/TEMPUR 2IN535653562018-04-18
00842430104497CMBU RADIOLUCENT DORO ADAPTER5979-3005979-3002018-05-10
00842430104503CMBU RADIOLUCENT MAYFIELD ADAPTER5979-2005979-2002018-05-10
00842430104541COUPLER II RADIOLUCENT DORO ADAPTER5873-3005873-3002018-04-26
00842430104947Levó Protective Arm Sleeve789278922019-03-08
00842430105098PIVOTING ARM BOARD W/TEMPUR 3IN535753572018-04-18

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00842430109027Avra Smart Hub Powered by BodiTrakMIZUHO ORTHOPEDIC SYSTEMS, INC.JFC2021-06-14
00842430110283AVRA HEAD SECTION 3IN STERIS 3080, 3085MIZUHO ORTHOPEDIC SYSTEMS, INC.JFC2021-06-14
00842430110290AVRA BACK SECTION 3IN STERIS 3080, 3085MIZUHO ORTHOPEDIC SYSTEMS, INC.JFC2021-06-14
00842430110306AVRA FOOT SECTION, 3IN, STERIS 3080, 3085MIZUHO ORTHOPEDIC SYSTEMS, INC.JFC2021-06-14
00842430110641AVRA 3-PC SET 3IN STERIS 3080 3085MIZUHO ORTHOPEDIC SYSTEMS, INC.JFC2021-06-14
00842430111266AVRA WIRELESS TABLET DISPLAYMIZUHO ORTHOPEDIC SYSTEMS, INC.JFC2021-06-14
B970303012503030-125 SensorTekscan, Inc.JFC2020-11-04
B9703000E12503000-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000E5003000-E-50 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000ES03000-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTE12503000SPORT-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTE5003000SPORT-E-50 F-Scan SensorTekscan, Inc.JFC2020-11-03
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