FDA.reportPublic FDA data

QFlow 500 2.7mm Drill Bit Kit

Primary DI
B238H000036110
Brand
QFlow 500 2.7mm Drill Bit Kit
Company
HEMEDEX, INC
Model
NA
Catalog number
H0000-3611
Device description
2.7mm Drill Bit Kit
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HBGDrills, Burrs, Trephines & Accessories (Manual)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBGDrills, Burrs, Trephines & Accessories (Manual)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141869000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141869000QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KITHemedex Incorporated2014-10-10GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B238H000036110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral catheterization drill bitA sterile drilling endpiece intended to be used for drilling the skull of a patient to facilitate the introduction and fixation of an intracerebral sensor/infusion/drainage catheter. It is intended to be attached to a manual or electric drilling device. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
128045676
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B238H000036120QFlow 500 5.3mm Drill Bit KitNAH0000-36122016-09-21
B238H000007100Bowman Perfusion Monitor, 120VModel 500H0000-07102016-09-21
B238H000016000QFlow 500 Perfusion ProbeNAH0000-16002016-09-21
B238H000036010QFlow 500 Titanium Bolt-Single LumenNAH0000-36012016-09-21
B238H000036020QFlow 500 Titanium Bolt-Dual LumenNAH0000-36022016-09-21
B238H000036310QFlow 500 Titanium Bolt-Single Lumen Bolt Kit NAH0000-36312016-09-21
B238H000036320QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit NAH0000-36322016-09-21
B238H000036420QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit with Introducer NAH0000-36422016-09-21
B238H000036440QFlow 500 Titanium Bolt-Quad Lumen Bolt Kit NAH0000-36442016-09-21
B238H000036810QFlow 500 Bolt Accessory KitNAH0000-36812016-09-23
B238H000036830QFlow 500 Probe Dura Piercer and Introducer KitNAH0000-36832016-09-21
B238H000036840QFlow 500 Quad Lumen Cranial Bolt Large-Lumen Introducer NAH0000-36842016-09-21
B238H000036850QFlow 500 Male-Female Luer CouplerNAH0000-36852016-09-21
B238H000107110Bowman Perfusion Monitor, 240VModel 500H0001-07112016-09-21

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