neoprobe

GUDID 00841911102274

GDS Console, Model 2400

DEVICOR MEDICAL PRODUCTS, INC.

Hand-held-detector nuclear medicine system

• Primary Device ID: 00841911102274
• NIH Device Record Key: c6a74b6a-ae5b-484e-bd2d-5c86eba439a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neoprobe
• Version Model Number: NPCU4
• Company DUNS: 961832156
• Company Name: DEVICOR MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-926-2666
• Email: customersupport@mammotome.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911102274 [Primary]

FDA Product Code

• IZD: Probe, Uptake, Nuclear

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-21
• Device Publish Date: 2019-05-13

On-Brand Devices [neoprobe]

• 00841911100355: Operation Manual Kit, Model 2300
• 00841911100348: F18 Probe, Model 1103
• 00841911100331: 14 mm Probe, Model 1017
• 00841911100324: 14 mm Collimator, Model 1013
• 00841911100317: GDS Console, Model 2300
• 00841911100300: Bluetooth Serial Port Adapter, Model 1131
• 00841911100294: Bluetooth Straight Probe, Model 1100
• 00841911100287: Bluetooth Angled Probe, Model 1101
• 00841911100270: Bluetooth Lap Probe, Model 1102
• 00841911100263: Bluetooth Straight Probe, Model 1104
• 00841911100256: Probe Cable, Model 2060
• 00841911100249: Cable, Model 2024
• 00841911100232: Power Cord, Model 2009
• 00841911100225: Accessory Case, Model 2010
• 00841911100218: Cart
• 00841911102274: GDS Console, Model 2400