AccessGUDID - DEVICE: ViraChip Scanner (EVIRUVCSCA1)

GUDID

Device Identifier (DI) Information

Brand Name: ViraChip Scanner
Version or Model: V-UVCSCA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: V-UVCSCA
Company Name: Viramed Biotech AG

Primary DI Number: EVIRUVCSCA1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 329748847 *Terms of Use

Device Description: ViraChip Scanner

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?
66400	Microplate digital imaging scanner IVD	An electrically-powered laboratory instrument intended to be used to scan a microplate containing a clinical specimen, to produce images in a digital format. It is a unit containing a tray slot and high-resolution camera(s) which is connected to an off-the-shelf computer (not included) for viewing and/or analysis of images via an external software application (not included).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQT	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 06f45d8e-058a-4230-8eb3-3f29b73554a0
Public Version Date: July 25, 2023
Public Version Number: 1
DI Record Publish Date: July 17, 2023

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +4989899336
Email: xx@xx.xx

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