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8 Product Identification Label
The performance characteristics of the device are defined on the product identification label as
part of the accompanying documents.
No.
01
02
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11
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15
X-Ray Tube AssembliesX-Ray Tube Assemblies
Label
Philips Medical Systems
DMC GmbH
Röntgenstraße 24
22335 Hamburg / GERMANY
yyyy-mm
Nominal X-ray Tube Voltage
THIS PRODUCT COMPLIES WITH THE
DHHS REQUIREMENT OF 21 CFR
SUB-CHAPTER J
MANUFACTURED:
month year
Designation
Registered trade name of the manufacturer
Registered trade mark of the manufacturer
Address of the legal manufacturer
Address of the legal manufacturer.
yyyy: year of manufacture
mm: month of manufacture
Type of the medical device: X-ray tube housing assembly
Name of the product
Type number of the product
Serial number of the product
Medical device product
Value of the permanent filtration
Dimensions of the small focus and the respective standard
Dimensions of the large focus and the respective standard
Value of the nominal X-ray tube voltage and the respective standard
X-ray tube
Compliance statement, for US only
Month and year of manufacture
Product Identification Label
21
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