NeedleCam HD System BVT01197-00001

GUDID 00851582006047

NeedleCam HD Visualization System

BIOVISION TECHNOLOGIES, LLC

Endoscopic video imaging system

• Primary Device ID: 00851582006047
• NIH Device Record Key: 0262b330-5edf-41b5-9bd1-04c85f8eac9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeedleCam HD System
• Version Model Number: BVT01197-00001
• Catalog Number: BVT01197-00001
• Company DUNS: 166160106
• Company Name: BIOVISION TECHNOLOGIES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Manufacturing Date: false
• 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: 303-237-9608
• Email: bray@biovisiontech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851582006047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143705

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-27

Devices Manufactured by BIOVISION TECHNOLOGIES, LLC

• 00851582006023 - OnPoint Disposable Scope Kit: 2018-07-06 OnPoint Disposable Scope with Instruments 1.2mm 0 Degree
• 00851582006047 - NeedleCam HD System: 2018-07-06NeedleCam HD Visualization System
• 00851582006047 - NeedleCam HD System: 2018-07-06 NeedleCam HD Visualization System
• 00851582006085 - InnerVue II 100mm Scope Kit: 2018-07-06 1.2mm Disposable InnerVue II Scope with Accessories 100mm WL, 10 Degree
• 00851582006092 - 1.2mm InnerVue II Scope Kit: 2018-07-06 1.2mm Disposable InnerVue II Scope with Accessories 65mm W.L., 10 Degree
• 00851582006108 - OnPoint Lite System: 2018-07-06 OnPoint Lite Visualization System
• 00851582006122 - NeedleView 0 Degree 65mm Scope Kit: 2018-07-06 1.2mm NeedleView 0 Degree 65mm Scope Kit
• 00851582006139 - NeedleView 0 Degree 100mm Scope Kit: 2018-07-06 1.2mm NeedleView 0 Degree 100mm Scope Kit
• 00851582006146 - NeedleView 10 Degree 65mm Scope Kit: 2018-07-06 1.2mm NeedleView 10 Degree 65mm Scope Kit