Midmark PREVA IntraOral Dental X-ray System

Primary DI
00841709101571
Brand
Midmark PREVA IntraOral Dental X-ray System
Company
MIDMARK CORPORATION
Model
DCD5‐W1B/S2
Catalog number
DCD5‐W1B/S2
Device description
Intraoral X-ray
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841709101571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709101571008417091015718417091015710841709101571

GMDN Terms

TermDefinition
Stationary intraoral dental x-ray system, digitalA diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-35 Degrees Celsius66 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-643-6275imagingtechsupport@midmark.com

Regulatory Flags

DUNS number
005036025
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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