FDA.reportPublic FDA data

HOPKINS

Primary DI
04048551355886
Brand
HOPKINS
Company
Karl Storz GmbH & Co. KG
Model
28095BAB
Device description
HOPKINS® Telescope 25°, 4 mm, 9 cm
Published
2017-03-02
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
HRXARTHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551355886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551355886040485513558864048551355886

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope telescopeAn optical device designed to provide the illumination and image transmission capabilities of a rigid endoscope. It typically includes a set of lenses (e.g., thin and rod-shaped lenses) and/or a fibreoptic bunch, and is introduced though the sheath of the endoscope (e.g., a rigid cystoscope or resectoscope). The endoscopic telescope is connected proximally to a light source, and the returning image is directly observed or scanned with a video camera. Dedicated types are available for direct, lateral, and oblique views. It is used for examination of body cavities following natural tracts (e.g., urinary, gastrointestinal) or surgical cavities (e.g., laparoscopic). This is a reusable device.

Sterilization Methods#

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

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

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Primary DI, Brand, Company table
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10810004821122Spinal Introducer SetCLARUS MEDICAL, LLCHRX2026-06-22
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
08809281659387BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2026-05-11
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08809281659370BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
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