FDA.reportPublic FDA data

BLUE 400

Primary DI
04049539070159
Brand
BLUE 400
Company
Carl Zeiss Meditec AG
Model
7015
Device description
accessory for surgical microscopes
Published
2024-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
QFXDiagnostic Neurosurgical Microscope Filter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFXDiagnostic Neurosurgical Microscope FilterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240215000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240215000BLUE 400; BLUE 400 SCarl Zeiss Meditec, AG2024-06-28QFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049539070159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049539070159040495390701594049539070159

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical microscopeA light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures within the neurological fields for surgery, typically the brain or spine or surroundings in the performance of neurological surgical procedures which require high magnification by transmitted light. It will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It is usually fixed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342228620
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049471097153SL 220SL 8002026-01-13
04049471091489VISULASVISULAS yag2026-01-12
04049471091496VISULASVISULAS combi2026-01-12
04049471091502VISULAS greenVISULAS green2026-01-12
04049471090260AT 030AT 0302018-12-04
04049471091229VISULAS TrionVISULAS Trion, VISULAS Trion VITE2016-09-20
04049471091403VISULAS 532sVISULAS 532s, VISULAS 532s VITE2016-09-20
04049539072122QEVO72122017-08-24
04049539072139QEVO ECU72132017-08-24
04049539105509INTRABEAM Spherical Sizer Set309121-9100-0002025-06-20
04049539105516INTRABEAM SMART Spherical Applicator309120-9015-002025-05-14
04049539105523INTRABEAM SMART Spherical Applicator 309120-9020-0002025-05-14
04049539105530INTRABEAM SMART Spherical Applicator 309120-9025-0002025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)309120-9035-0002025-05-14
04049539105554INTRABEAM SMART Spherical Applicator (35mm)309120-9035-0002025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)309120-9040-0002025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)309120-9045-0002025-05-14
04049539101563INTRABEAM® Spherical Applicator 1.5 cm304534-6000-5572017-04-14
04049539101570INTRABEAM® Spherical Applicator 2.0 cm304534-6000-5582017-04-14
04049539101587INTRABEAM® Spherical Applicator 2.5 cm304534-6000-5592017-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630802403414FL400 for M530Leica Microsystems (Schweiz) AGQFX2025-10-09
04049539070593BLUE 400 SCarl Zeiss Meditec AGQFX2024-10-07
00816744027728NICO Myriad SPECTRANICO CORPORATIONQFX2024-06-07
00816744027483NICO Myriad SPECTRANICO CORPORATIONQFX2024-04-01
00816744027537NICO Myriad SPECTRANICO CORPORATIONQFX2024-04-01