AccessGUDID - DEVICE: CR HD5.0 AEC DETECTOR (05414904044186)

GUDID

Device Identifier (DI) Information

Brand Name: CR HD5.0 AEC DETECTOR
Version or Model: CR HD5.0 AEC DETECTOR 18X24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5PCPT
Company Name: AGFA

Primary DI Number: 05414904044186
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 374444883 *Terms of Use

Device Description: CR HD5.0 AEC DETECTOR 18X24CM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44824	Digital imaging cassette/phosphor plate	A device that includes both a digital imaging cassette and a phosphor plate (also known as screen) intended to receive radiation by a diagnostic x-ray system, to record a patient radiation pattern during a non-dental procedure. The device is then transferred, with the cassette shielding the plate from environmental light, to a computed radiography (CR) scanner for insertion to produce the digital image of the patient. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQB	Solid state x-ray imager (flat panel/digital imager)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141602	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 18 Centimeter
Width: 24 Centimeter

Device Record Status

Public Device Record Key: e1f5499c-031a-441f-b1ae-9b6128b8f6df
Public Version Date: June 19, 2024
Public Version Number: 6
DI Record Publish Date: September 01, 2016

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)777-2432
Email: salesinfo@agfa.com

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