FDA.reportPublic FDA data

Drill Guide Kit (0.085'')

Primary DI
04056481006402
Brand
Drill Guide Kit (0.085'')
Company
Brainlab SE
Model
19779
Catalog number
19779
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
HCACatheter, Ventricular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
HCACatheter, VentricularNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123605000
K132436000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123605000SMARTFLOW CATHETERMri Interventions, Inc.2013-08-16HCA
K132436000VARIOGUIDE DRILL KITMri Interventions, Inc.2014-03-20HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481006402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481006402040564810064024056481006402

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49899915680contact@brainlab.com

Regulatory Flags#

DUNS number
314482980
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481147648Quip Link Instrument Tracking Array For 3 Marker Spheres M581932026-10-29
04056481147655Quip Link Instrument Tracking Array For 3 Marker Spheres ML581942026-10-29
04056481147662Quip Link Instrument Tracking Array For 3 Marker Spheres L581952026-10-29
04056481147679Quip Link Instrument Tracking Array For 3 Marker Spheres L1581962026-10-29
04056481147686Quip Link Instrument Tracking Array For 3 Marker Spheres L2581972026-10-29
04056481147693Quip Instrument Adapter Clamp Size S582102026-10-29
04056481147709Quip Instrument Adapter Clamp Softgrip Size M582112026-10-29
04056481147716Quip Instrument Adapter Clamp Softgrip Size L582122026-10-29
04056481147723Quip Instrument Adapter Clamp Softgrip Size XL582132026-10-29
04056481147730Quip Instrument Adapter Clamp For Rectangular Instruments582142026-10-29
04056481147747Quip Instrument Adapter Clamp For Cylindrical Instruments582152026-10-29
04056481147754Quip Instrument Adapter Extension 50 mm582162026-10-29
04056481147761Quip Instrument Adapter 45° Angled582172026-10-29
04056481145323Patient Reference Carbon-Clamp Spine & Trauma558232026-10-27
04056481148201Sterilization Tray Accessories Spine52306C2026-10-27
04056481148218Sterilization Tray Accessories Spine & Trauma52326A2026-10-27
04056481148225Sterilization Tray Accessories Spine MIS52313B2026-10-27
04056481148232Sterilization Tray Accessories ENT/CMF52311A2026-10-27
04056481148249Sterilization Tray Accessories Cranial (2 of 2)52305A2026-10-27
04056481146207Spine Planning3.02026-10-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816589021615Brasseler Twist DrillbitMONTERIS MEDICAL INCHBE2026-07-03
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04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
07630055505675PM2-A70Bien-Air Surgery SAHBE2023-02-09
07630055505682PM2-A150Bien-Air Surgery SAHBE2023-02-09
07630055505699PM2-S70Bien-Air Surgery SAHBE2023-02-09
07630055505705PM2-A95Bien-Air Surgery SAHBE2023-02-09
07613327504019NASTRYKER CORPORATIONHBE2021-07-08
07613327504057NASTRYKER CORPORATIONHBE2021-07-08
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2021-05-21
00763000216719CD HORIZON® SOLERA® VOYAGER™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HBE2020-12-31
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2019-06-08
10887587057026NASynthes GmbHHBE2019-02-22
04546540246332NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246356NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
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04546540251862NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540337818DELTAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540337825DELTAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540337900DELTAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356499NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356505NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356512NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356529NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356536NAStryker Leibinger GmbH & Co. KGHBE2016-08-24