FDA.reportPublic FDA data

Henke-Sass Wolf

Primary DI
00678467507235
Brand
Henke-Sass Wolf
Company
H & A Mui Enterprises Inc
Model
8300038301
Device description
Nasopharyngoscope (Flexible/rigid)
Published
2020-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00678467507235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00678467507235006784675072356784675072350678467507235

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic nasopharyngolaryngoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the structures inside the nasal passages, including the sinus openings, the pharyngeal end of the auditory tube, the larynx, and the vocal cords. It is inserted through a nostril and typically provides the operator with greater manoeuvrability (flexibility of the distal end) for improved viewing during nasopharyngolaryngoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-890-5525Quality@muiscientific.com

Regulatory Flags#

DUNS number
243872611
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10678467508437Mui ScientificS7-E22-10042026-04-15
00678467000422Mui ScientificR8B-3-0-0-0-0-0-0-02016-09-23
00678467000446Mui ScientificR8B-3-.5-.5-.5-.5-.5-.5-.52016-09-23
10678467508246Mui ScientificS7-E16-10262025-04-10
10678467508253Mui ScientificS7-R8-10572025-04-15
10678467508345Mui ScientificS7-R24-10442025-08-26
00678467000705Mui ScientificSPE4-3-3-32016-09-23
00678467000712Mui ScientificSPE4-5-5-52016-09-23
00678467503978Mui ScientificCE4-11902019-09-05
00678467504098Mui Scientific CE4-11372019-09-05
00678467504142Mui Scientific CR4-10872019-09-05
00678467504203Mui Scientific CR4-10882019-09-05
00678467504227Mui Scientific CR5-10282019-09-05
00678467504258Mui Scientific CE5-10762019-09-05
00678467504272Mui Scientific CE4-11952019-09-05
00678467505330Mui Scientific CE4-12512019-09-05
00678467502865Mui ScientificCE5-00452019-06-13
00678467503145Mui ScientificCE4-00352019-06-13
00678467502414Mui ScientificCE4-10742019-06-12
00678467500694Mui ScientificCE1-A-E57-OSH-22016-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04953170467592DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04961333255238VIVIDEOHOYA CORPORATIONEOB2025-12-19
04961333255306VIVIDEOHOYA CORPORATIONEOB2025-12-19
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.EOB2024-11-14
00858119004194Entity XL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004200Entity SDXL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004217Entity XL USB NasopharyngoscopeOPTIM LLCEOB2024-06-19
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06970462546382Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546399Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
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06970462546412Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546429Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546436Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546443Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546191Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
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00821925041479InstaClearGyrus ACMI, LLCEOB2024-04-22
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00821925041493InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041509InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041516InstaClearGyrus ACMI, LLCEOB2024-04-22