FDA.reportPublic FDA data

Midmark PREVA IntraOral Dental X-ray System

Primary DI
00841709102646
Brand
Midmark PREVA IntraOral Dental X-ray System
Company
MIDMARK CORPORATION
Model
30-A2195
Catalog number
30-A2195
Device description
Intraoral X-ray MODULAR BLD, 70 MM CONE
Published
2016-09-22
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
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709102646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709102646008417091026468417091026460841709102646

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray system collimatorA beam restriction device used in dental x-ray systems to determine the dimension and direction of the x-ray beam, limiting the effects of scattered radiation. It is used to control the size and shape of the x-ray beam reaching the patient's oral cavity and the film or image receptor. It includes all kinds of x-ray beam restriction devices used in diagnostic dental x-ray systems, such as cones and slit collimators. The device is typically designed for use with a specific dental x-ray system.

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
00841709110337Midmark153603LR-E153603LR-E2020-05-22
00841709110344Midmark153604CE153604CE2020-05-22
00841709110375Midmark153604LRCA-E153604LRCA-E2020-05-22
00841709110382Midmark153604LR-E153604LR-E2020-05-22
00841709111839Midmark153603C153603C2020-05-22
00841709108907Midmark153592-002153592-0022020-10-30
00841709108969Midmark153758-002153758-0022020-10-30
00841709107320Midmark153901-001153901-0012018-05-31
00841709107344Midmark153901-003153901-0032018-05-31
00841709107351Midmark153901-004153901-0042018-05-31
00841709107368Midmark153901-005153901-0052018-05-31
00841709107375Midmark153901-006153901-0062018-05-31
00841709109393Midmark153901-007153901-0072018-05-31
00841709109409Midmark153901-008153901-0082018-05-31
00841709124808Ritter228-001228-0012026-08-27
00841709124815Ritter228-002228-0022026-08-27
00841709124822Ritter228-003228-0032026-08-27
00841709124846Ritter229-002229-0022026-08-27
00841709124853Ritter229-003229-0032026-08-27
00841709125638MidmarkLT-1100-002LT-1100-0022026-07-08

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D090800048750NOMAD Pro 3 Packaged System, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048870NOMAD Pro 3 Packaged System, US Dental Imaging Technologies CorporationEHD2026-03-31
08809840720046WeRayPICOPACK Inc.EHD2024-10-24
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