FDA.report

n.a.

Primary DI
04048551084700
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
24960
Device description
Fiber Optic Light Carrier
Published
2018-08-21
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
FCWLight source, fiberoptic, routine

Product Code Classifications

CodeDeviceSpecialtyClass
FCWLight Source, Fiberoptic, RoutineGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551084700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551084700040485510847004048551084700

GMDN Terms

TermDefinition
Optical proctoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through direct or magnified viewing, or a fibreoptic bundle. This device is longer than an anoscope to provide a deeper view. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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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