FDA.report

BELCYPHER PRO

Primary DI
04560217095634
Brand
BELCYPHER PRO
Company
TAKARA-BELMONT CO., LTD.
Model
BELCYPHER PRO
Catalog number
BELCYPHER PRO
Device description
BELCYPHER-PRO 120V/60HZ
Published
2017-04-05
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

Product Codes

CodeName
MUHSystem,x-ray,extraoral source,digital

Product Code Classifications

CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560217095634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04560217095634045602170956344560217095634

GMDN Terms

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

TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+810662135945e-nishizawa@belmont.jp

Regulatory Flags

DUNS number
690540349
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
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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