AccessGUDID - DEVICE: Ortho CP-GU M (05414904197585)

GUDID

Device Identifier (DI) Information

Brand Name: Ortho CP-GU M
Version or Model: ORTHO CP-GU M 24x30
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 55BK1
Company Name: AGFA

Primary DI Number: 05414904197585
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 374444883 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
40979	Medical x-ray film, screen	A screen x-ray film specifically designed for medical diagnostic imaging applications. It is sensitive primarily to wavelengths of light emitted from an image intensifying screen or other visible light source. It is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material. This film is not limited to use with x-ray imaging systems but can also be used in a variety of diagnostic imaging modalities using image intensifier technology or matrix formatters to output images, e.g., nuclear medicine or ultrasound.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWZ	Film, radiographic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 30 Centimeter
Length: 24 Centimeter

Device Record Status

Public Device Record Key: 2aa76297-239f-497e-b92a-b2f46dd2d032
Public Version Date: November 01, 2022
Public Version Number: 1
DI Record Publish Date: October 24, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05414904220825	5	05414904197585		In Commercial Distribution

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 05414904220818 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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