FDA.reportPublic FDA data

CranioFlex™-C

Primary DI
03760187910765
Brand
CranioFlex™-C
Company
MAUNA KEA TECHNOLOGIES
Model
211-0175
Catalog number
MP-0022-CRF
Published
2018-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWGEndoscope, Neurological
OWNConfocal Optical Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWGEndoscope, NeurologicalNeurology2
OWNConfocal Optical ImagingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180270000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180270000Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies2018-05-22GWG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760187910765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760187910765037601879107653760187910765

GMDN Terms#

Term, Definition table
TermDefinition
Confocal endomicroscopy system probeA minimally-invasive distal component of an endomicroscopy system intended to capture real-time images of microscopic cellular and tissue structures during an endoscopic procedure. It is a flexible fibreoptic bundle typically connected to a laser scanning unit that channels a laser beam to the anatomical site of interest and allows visualization by detecting the fluorescence emitted by the cells in the targeted region. This is a reusable device intended to be sterilized or disinfected prior to use.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
+33170080967support@maunakeatech.com

Regulatory Flags#

DUNS number
394136118
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760187910055ColoFlex™ UHD211-0134MP-0006-HDC2016-09-24
03760187910079GastroFlex™ UHD211-0072MP-0009-HDG2016-09-24
03760187913001Cellvizio® I.V.E.FP-100012024-02-28
03760187910772AQ-Flex™ 19-C211-0211MP-0023-AQF2023-02-09
03760187912011AlveoFlex™ NFP-100292020-05-15
03760187912028GastroFlex™ NFP-100302020-05-15
03760187912035ColoFlex™ NFP-100312020-05-15
03760187912042CystoFlex™ R NFP-100322020-05-15
03760187912059AQ-Flex™ 19 NFP-100332020-05-15
03760187912073CholangioFlex™ NFP-100352020-05-15
03760187912080CelioFlex™ 5 NFP-100362020-05-15
03760187912097UroFlex™ NFP-100372020-05-15
03760187912103CystoFlex™ F NFP-100382020-05-15
03760187912004Cellvizio® I.V.E.FP-100012020-05-15
00827002472693Cellvizio® 100 series (488nm)210-0027CS-100-448-CK-12016-12-12
00827002472716Cellvizio® 100 series (488nm)210-0027CS-100-488-CK-32016-12-12
00827002472730UroFlex™B211-0142MP-0011-URF-CK2016-12-12
00827002472747CystoFlex™F211-0146MP-0012-CYS-CK2016-12-12
00827002472754CystoFlex™UHD R211-0147MP-0013-HCYS-CK2016-12-12
03760187910758CranioFlex™211-0174MP-0021-CRF2018-10-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850016403032ActivSight Light Cable Adapter - StrykerActiv Surgical, Inc.OWN2026-05-26
00850016403087ActivSight Light Cable Adapter - StorzActiv Surgical, Inc.OWN2026-05-26
00850016403094ActivSight Integrated Imaging ModuleActiv Surgical, Inc.OWN2026-05-26
00850016403124ActivSight Light Cable Adapter - Olympus IRActiv Surgical, Inc.OWN2026-05-26
00850016403162ActivSight Light Cable Adapter - Storz IRActiv Surgical, Inc.OWN2026-05-26
08800112400161cCeLLVPIX Medical, Inc.GWG2026-05-11
08800112400178cCeLLVPIX Medical, Inc.GWG2026-05-11
00860000321389Neuroblade SystemClearmind Biomedical Inc.GWG2026-05-11
00810004821064Clarus Digital ChannelScope Endoscope, 21.6cm, 3mm WCCLARUS MEDICAL, LLCGWG2026-04-21
00810004821071Clarus Digital ChannelScope Endoscope, 13.0cm, 3mm WCCLARUS MEDICAL, LLCGWG2026-04-21
00810004821118Digital MurphyScope EndoscopeCLARUS MEDICAL, LLCGWG2026-04-21
00840067103029ZenithCADWELL INDUSTRIES, INC.GWG2025-12-31
04953170445538OTV-S700 UPGRADE PACK IROLYMPUS MEDICAL SYSTEMS CORP.OWN2025-11-21
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