DEVICE: BELCYPHER-N (04560217093692)

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Device Identifier (DI) Information

BELCYPHER-N
BELCYPHER
BELCYPHER-N
TAKARA-BELMONT CO., LTD.
04560217093692
GS1
1
BELCYPHER-N CMOS 120V/60HZ
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Stationary panoramic dental x-ray system, digital A 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.
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FDA Product Code

[?]
Product Code Product Code Name
MUH System,x-ray,extraoral source,digital
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 60 Degrees Celsius
Handling Environment Temperature: between 5 and 35 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 21, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)223-1192
gstern@belmontequip.com
+810662135945
e-nishizawa@belmont.jp
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