declipse®SPECT

Basic Information

• Brand Name: declipse®SPECT
• Primary DI: ESURSE13010002
• Version / Model: declipseSPECT Viewer
• Catalog Number: SE 1301-0002
• Company Name: SurgicEye GmbH
• Labeler DUNS: 340279325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-17
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 823cf8c0-460a-464e-86a9-f71f32cae389

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZD	Probe, Uptake, Nuclear	Radiology	892.1320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	ESURSE13010002	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123917	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal