DEVICE: Ceph attachment with sensor (00841709102752)

Device Identifier (DI) Information

Ceph attachment with sensor
C6000
In Commercial Distribution
C6000
MIDMARK CORPORATION
00841709102752
GS1

1
005036025 *Terms of Use
Ceph attachment with sensor
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
43620 Stationary cephalometric x-ray system, digital
A stationary cephalometric x-ray system designed to generate and control x-ray beams and to record the absorption patterns of x-rays passing through a patient's head (skull). It is used for: 1) radiographic visualization and measurement of the dimensions of the human head, e.g., abnormal structures of the skull; 2) orthodontic assessment of the relationship of the teeth to the jaws and the jaws to the rest of the facial skeleton; 3) assessment airway and other soft tissue structures. The sensor is placed outside the head. The data is either from analogue imaging and digitized afterwards or by digital imaging.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MUH System,X-Ray,Extraoral Source,Digital
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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Storage and Handling
Handling Environment Humidity: between 5 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 35 Degrees Celsius
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

88aad3cc-ab25-42da-aa66-979cb8d2947a
March 29, 2018
2
September 22, 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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
1-800-634-6275
imagingtechsupport@midmark.com
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