neoprobe

Basic Information

• Brand Name: neoprobe
• Primary DI: 00841911100324
• Version / Model: NPE14
• Company Name: DEVICOR MEDICAL PRODUCTS, INC.
• Labeler DUNS: 961832156
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 74cacb01-4f98-47df-9f77-162126fc0709

Device Description

14 mm Collimator, Model 1013

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
42256	Single-hole nuclear medicine system collimator, straight-bore	An individual hollow-bore cylinder made of a dense material, e.g., lead (Pb), tungsten (W) or titanium (Ti), used to ensure that only gamma ray activity directly in front of the collimator channel reaches the scintillation crystal of the imaging or detector system. This GMDN code includes collimators designed to image low, medium or high-energy photons. It can be an integrated component of a hand-held probe, a detector array, or other kind of detector or imaging system, and includes interchangeable designs. It has attachment mechanisms enabling it to be safely transported, removed from, or attached to the detector head of a detector or imaging system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841911100324	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius