AccessGUDID - DEVICE: declipse®SPECT (ESURSE13010002)

GUDID

Device Identifier (DI) Information

Brand Name: declipse®SPECT
Version or Model: declipseSPECT Viewer
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SE 1301-0002
Company Name: SurgicEye GmbH

Primary DI Number: ESURSE13010002
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 340279325 *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:	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?
38333	Scintillation radiation measuring probe	A component of a portable survey meter or stationary radiation monitor used to measure radioactive emissions. It includes a variety of designs and configurations consisting of a crystal or other form of scintillation material, a photomultiplier tube, a light reflector, light "pipes" that transmit the light to the photomultiplier tube, and a connector to attach it to the survey meter. The composition and size of the scintillation material determines the energy discrimination capabilities of a scintillation probe design and defines the kind of radiation, e.g., x-ray, gamma ray, high-energy beta particles or neutrons, that can be detected.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZD	Probe, Uptake, Nuclear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123917	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
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Handling Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 50 Degrees Celsius
Storage Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 823cf8c0-460a-464e-86a9-f71f32cae389
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 17, 2018