FDA.report

PANOVIEW

Primary DI
04055207010358
Brand
PANOVIEW
Company
Richard Wolf GmbH
Model
846230
Catalog number
8462.30
Device description
TELESCOPE 0° Ø 2.7MM WL 310MM rigid, TL 371mm, rod lens system
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
GCMENDOSCOPE, RIGID

Product Code Classifications

CodeDeviceSpecialtyClass
GCMEndoscope, RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207010358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207010358040552070103584055207010358

GMDN Terms

TermDefinition
Rigid bronchoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the trachea, primary bronchi, and upper regions of the lungs. It is inserted through the mouth during the procedure called bronchoscopy. The inserted portion has an internal lumen sufficiently large to permit free respiration of the patient. The anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. It is used to diagnose lung infections, pneumonia, lung cancer, and allows physicians to view the upper regions of the lungs and take biopsies and samples of secretions. This is a reusable device.

Device Sizes

TypeValueUnit
Angle0degree
Length310Millimeter
Outer Diameter2.7Millimeter

Sterilization Methods

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

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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