FDA.report

n.a.

Primary DI
04048551272268
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
11577A
Device description
Mini Straight Forward Telescope 0°, 1 mm
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
EIAUNIT, OPERATIVE DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551272268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551272268040485512722684048551272268

GMDN Terms

TermDefinition
SialendoscopeAn endoscope with a slender semiflexible inserted portion intended for the visual examination and treatment of the salivary ducts. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used in combination with special instruments (e.g., forceps, laser probes, stone extractors) to locate and extract/treat a salivary stone (sialolithiasis) and/or a stricture (sialostenosis) in the submandibular, parotid, and/or sublingual salivary duct. This is a reusable device intended to be sterilized before use.

Sterilization Methods

Method
Ethylene Oxide;Liquid Chemical;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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