AccessGUDID - DEVICE: SCINTRON (04260484140050)

GUDID

Device Identifier (DI) Information

Brand Name: SCINTRON
Version or Model: SCINTRON
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MiE medical imaging electronics GmbH

Primary DI Number: 04260484140050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 537604915 *Terms of Use

Device Description: Gamma Camera Workstation for Acquisition, Reviewing and Processing

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?
40969	Nuclear medicine system operator console, multi-purpose	A multi-purpose device that can be a component of a nuclear medicine (NM) imaging system, e.g., a single photon emission computed tomography (SPECT), positron emission tomography (PET) or a gamma camera and which functions as the primary control panel. It typically includes hardware and software that allows for image display, processing, analysis, archiving and retrieval. It typically includes the capabilities to be interfaced with a picture archiving and communication system (PACS), a local area network (LAN), a radiology information system (RIS) or a hospital information system (HIS). It contains the primary controls for the direct operation of the main system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPS	System, Tomography, Computed, Emission

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101013	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: 1c7632fe-c1e0-46c2-8ccf-431d2b6df073
Public Version Date: August 27, 2018
Public Version Number: 1
DI Record Publish Date: July 25, 2018

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: +49419499770
Email: mie@miegermany.de

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