DEVICE: CR MD4.0 GENERAL CASSETTE (05414904028988)
Device Identifier (DI) Information
CR MD4.0 GENERAL CASSETTE
CR MD4.0 GENERAL CASSETTE 10x12
In Commercial Distribution
37PRK
AGFA
CR MD4.0 GENERAL CASSETTE 10x12
In Commercial Distribution
37PRK
AGFA
CR MD4.0 GENERAL CASS HR 10X12I
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44823 | Digital imaging cassette |
A device used in medical imaging applications to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic imaging x-ray system and a computed radiography scanner, in the process of producing a digital image of a patient radiation pattern.
|
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 [?] |
---|---|
K041701 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 10 Inch |
Width: 12 Inch |
Device Record Status
f46902d8-8442-4fa0-b2f6-062752b95b12
June 14, 2019
4
September 01, 2016
June 14, 2019
4
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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)777-2432
salesinfo@agfa.com
salesinfo@agfa.com