FDA.report

NA

Primary DI
04055207009482
Brand
NA
Company
Richard Wolf GmbH
Model
825638
Catalog number
8256.38
Device description
ESOPHAGOSCOPE-TUBE ID 11.5X7.5MM model Wolf, OD 13.5x9.5mm, TL 294mm, with fixed distal light carrier, graduated, reusable
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EOXESOPHAGOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207009482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207009482040552070094824055207009482

GMDN Terms

TermDefinition
Rigid oesophagoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a reusable device.

Sterilization Methods

Method
Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
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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