FDA.report

NA

Primary DI
04055207000014
Brand
NA
Company
Richard Wolf GmbH
Model
WA52050A
Catalog number
WA52050A
Device description
VIDEO-MEDIASTINOSCOPE WL 158MM
Published
2016-09-23
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
EWYMEDIASTINOSCOPE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EWYMediastinoscope, SurgicalEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207000014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207000014040552070000144055207000014

GMDN Terms

TermDefinition
Rigid mediastinoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the mediastinum (the intrapleural space located behind the sternum). It is inserted into the body through an artificial orifice created by an incision made during mediastinoscopy. 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 structures such as lymph nodes during a staging evaluation of lung cancer, or to establish the diagnosis of a tumour that is localized to the mediastinum. This is a reusable device.

Device Sizes

TypeValueUnit
Length158Millimeter

Sterilization Methods

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

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
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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