AccessGUDID - DEVICE: Drystar 5503 (05414904015674)

GUDID

Device Identifier (DI) Information

Brand Name: Drystar 5503
Version or Model: 5364/300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ESKZV
Company Name: AGFA

Primary DI Number: 05414904015674
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 374444883 *Terms of Use

Device Description: DRYSTAR 5503

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:	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?
17508	Video printer	A device designed for making printed (hard) copies of medical video images. These can be taken by digital cameras or image processing results of different imaging devices or systems [e.g., ultrasound (US), magnetic resonance imaging (MRI), computed tomography (CT) or radiographic images].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMC	Camera, multi format, radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023287	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
No Device Sizes

Device Record Status

Public Device Record Key: 5e38de21-1d96-41fe-a5dd-ea46af62fca9
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: 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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