FDA.reportPublic FDA data

Pan system with ceph sensor, export

Primary DI
00841709102813
Brand
Pan system with ceph sensor, export
Company
MIDMARK CORPORATION
Model
V5150
Catalog number
V5150
Device description
Pan system with ceph sensor, export
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUHSystem,X-Ray,Extraoral Source,Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709102813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709102813008417091028138417091028130841709102813

GMDN Terms#

Term, Definition table
TermDefinition
Stationary panoramic dental x-ray system, digitalA diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams to produce panoramic (wide field of view) x-ray images of the teeth, jaw and oral cavity structures. It consists of basic modular configurations that can be upgraded by the addition of hardware, software or other components. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-35 Degrees Celsius66 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-634-6275imagingtechsupport@midmark.com

Regulatory Flags#

DUNS number
005036025
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709105791MidmarkIQvitals Zone, w/Nellcor SPO21-200-03202021-05-17
00841709105784MidmarkIQvitals Zone1-200-03102017-04-07
00841709105807MidmarkIQvitals Zone w/Masimo SPO21-200-03302017-04-07
00841709105814MidmarkIQvitals Zone, w/Wireless1-200-03402017-04-07
00841709105821MidmarkIQvitals Zone, w/Nellcor SPO2 and Wirless1-200-03502017-04-07
00841709105838MidmarkIQvitals Zone, w/Masimo SPO2 and Wireless1-200-03602017-04-07
00841709105869MidmarkIQvitals Zone, Non-Wireless4-000-06202017-04-07
00841709105876MidmarkIQvitals Zone, Non-Wireless with Nellcor SPO24-000-06222017-04-07
00841709105883MidmarkIQvitals Zone, Non-Wireless with Masimo SPO24-000-06242017-04-07
00841709105890MidmarkIQvitals Zone, Wireless without SPO24-000-07202017-04-07
00841709105906MidmarkIQvitals Zone, Wireless with Nellcor SPO24-000-07222017-04-07
00841709105913MidmarkIQvitals Zone, Wireless with Masimo SPO24-000-07242017-04-07
00841709107948MidmarkG3G32019-02-08
00841709107979MidmarkG5G52019-02-08
00841709107993MidmarkG6G62019-02-08
00841709108006MidmarkG7G72019-02-08
00841709108020MidmarkG14G142019-02-08
00841709108037MidmarkG10G102019-02-08
00841709108099MidmarkP21/CV3P21/CV32019-02-08
00841709108112MidmarkP21P212019-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800011200060Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
D090101397120IXS S2 Kit, CT, US, FR-CADental Imaging Technologies CorporationMUH2026-05-12
D090101329460DEXIS IXS Size 1 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090101329470DEXIS IXS Size 2 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090800045720DEXIS Ti2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045730DEXIS IXS Size 1 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045750DEXIS IXS Size 2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045770DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045780DEXIS IXS Size 2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800045790DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045810DEXIS IXS S2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045830DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045840DEXIS Ti2 Kit - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045850IXS S1 Warranty Replacement - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045860IXS S1 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045870IXS S2 Warranty NEW KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045880IXS S2 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049760DEXIS Ti2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049770DEXIS IXS Size 1 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049790DEXIS Ti2 Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049800DEXIS Ti2 Sensor & Acc. Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049810DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049820DEXIS IXS Size 2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800457100DEXIS Ti2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
08800000500164Cocoon SoloDEXCOWIN CO., LTD.MUH2026-03-31
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