QFlow 500 5.3mm Drill Bit Kit H0000-3612

GUDID B238H000036120

5.3mm Drill Bit Kit

HEMEDEX, INC

Intracerebral catheterization drill bit

• Primary Device ID: B238H000036120
• NIH Device Record Key: de3a1af5-9098-4354-ade3-95e609e00140
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QFlow 500 5.3mm Drill Bit Kit
• Version Model Number: NA
• Catalog Number: H0000-3612
• 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: false
• 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	B238H000036120 [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

[B238H000036120]

Ethylene Oxide

[B238H000036120]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• 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: 2018-11-225.3mm 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: 2018-07-06 Intracranial Single Lumen Bolt Kit
• B238H000036320 - QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit: 2018-07-06 Intracranial Dual Lumen Bolt Kit