AccessGUDID - DEVICE: COMPACT 2 (04260502640005)

GUDID

Device Identifier (DI) Information

Brand Name: COMPACT 2
Version or Model: 1190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1190-2-1000
Company Name: PROTEC GmbH & Co. KG

Primary DI Number: 04260502640005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314629130 *Terms of Use

Device Description: Darkroom automated x-ray film processor

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):	No
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?
41011	Darkroom automated x-ray film processor	A mains electricity (AC-powered) automated darkroom film processing device in which x-ray/radiographic film must be manually removed from a cassette and loaded into the processor in a darkroom setting. It is designed to transport x-ray or radiographic film from one solution to the next in the developing process without any manual labour except the insertion of the film. It has typically six main sub-systems: transport, temperature, circulation, replenishment, drying and electrical control.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXW	Processor, Radiographic-Film, Automatic

FDA Premarket Submission

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

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
Handling Environment Temperature: between 18 and 40 Degrees Celsius
Handling Environment Humidity: between 50 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b4e02ad2-1655-4138-ada1-b3173ef9fcca
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 28, 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

[?]

No Customer Contact currently defined

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