QFlow 500 Titanium Bolt-Single Lumen Bolt Kit H0000-3631

GUDID B238H000036310

Intracranial Single Lumen Bolt Kit

HEMEDEX, INC

Intracerebral catheter cranial-fixation kit

• Primary Device ID: B238H000036310
• NIH Device Record Key: ee81ae53-821c-4db2-b3d0-d10e49bcfa7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QFlow 500 Titanium Bolt-Single Lumen Bolt Kit
• Version Model Number: NA
• Catalog Number: H0000-3631
• Company DUNS: 128045676
• Company Name: HEMEDEX, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B238H000036310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141869

FDA Product Code

• HBG: Drills, Burrs, Trephines & Accessories (Manual)

Sterilization

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

[B238H000036310]

Ethylene Oxide

[B238H000036310]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

Devices Manufactured by HEMEDEX, INC

• B238H000036110 - QFlow 500 2.7mm Drill Bit Kit: 2018-11-22 2.7mm Drill Bit Kit
• B238H000036120 - QFlow 500 5.3mm Drill Bit Kit: 2018-11-22 5.3mm Drill Bit Kit
• B238H000007100 - Bowman Perfusion Monitor, 120V: 2018-07-06 Perfusion Monitor, 120V
• B238H000016000 - QFlow 500 Perfusion Probe: 2018-07-06 Thermal Diffusion Probe
• B238H000036010 - QFlow 500 Titanium Bolt-Single Lumen: 2018-07-06 Intracranial Single Lumen Bolt
• B238H000036020 - QFlow 500 Titanium Bolt-Dual Lumen: 2018-07-06 Intracranial dual lumen bolt
• B238H000036310 - QFlow 500 Titanium Bolt-Single Lumen Bolt Kit: 2018-07-06Intracranial Single Lumen Bolt Kit
• B238H000036310 - QFlow 500 Titanium Bolt-Single Lumen Bolt Kit: 2018-07-06 Intracranial Single Lumen Bolt Kit
• B238H000036320 - QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit: 2018-07-06 Intracranial Dual Lumen Bolt Kit