AccessGUDID - DEVICE: CURIX ORTHO REGULAR (05414904006511)

GUDID

Device Identifier (DI) Information

Brand Name: CURIX ORTHO REGULAR
Version or Model: CURIX ORTHO REGULAR 15X30
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 38XZ8
Company Name: AGFA

Primary DI Number: 05414904006511
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 374444883 *Terms of Use

Device Description: CURIX CAS EU+OR REG 15X30

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?
35437	X-ray film cassette, manual	A device used in medical imaging applications to shield x-ray film from exposure to room light during transport and insertion into a diagnostic imaging system, film formatter, or film processor. It is typically designed for use with a particular imaging system or image formatting unit and consists of a plastic or metal housing with removable metal or plastic inserts. Some film cassettes used in x-ray applications can incorporate an x-ray grid into the cassette design.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXA	Cassette, radiographic film

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023020	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
Width: 30 Centimeter
Length: 15 Centimeter

Device Record Status

Public Device Record Key: 2b8ddc2d-b70a-47ca-a535-b08663dc8526
Public Version Date: June 14, 2019
Public Version Number: 4
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: Yes
Serial Number: No
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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