FDA.report

HOPKINS

Primary DI
04048551054376
Brand
HOPKINS
Company
Karl Storz GmbH & Co. KG
Model
1232AA
Device description
HOPKINS® Telescope 0°, Ø 1.9 mm, 10 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
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications

CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551054376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551054376040485510543764048551054376

GMDN Terms

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
Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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04048551061343NA20090331200903312025-03-28

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