FDA.reportPublic FDA data

HOPKINS

Primary DI
04048551054321
Brand
HOPKINS
Company
Karl Storz GmbH & Co. KG
Model
1230CA
Device description
HOPKINS® Telescope 70°, Ø 2.7 mm, 11 cm
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04048551054321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551054321040485510543214048551054321

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, endoscopicAn endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide"", ""Hydrogen Peroxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

Regulatory Flags#

DUNS number
315731430
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319759011Hayden MedicalHayden Medical, Inc.EOB2026-05-01
04719872715016MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04719872715023MiiS Horus Video BoxMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
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
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546368Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546375Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546382Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546399Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546405Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
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
00821925041462InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041479InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041486InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041493InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041509InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041516InstaClearGyrus ACMI, LLCEOB2024-04-22