FDA.report

PANOVIEW

Primary DI
04055207010402
Brand
PANOVIEW
Company
Richard Wolf GmbH
Model
846530
Catalog number
8465.30
Device description
TELESCOPE 0° Ø 5.5MM WL 488MM rigid, TL 564mm, 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
04055207010402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207010402040552070104024055207010402

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
Length488Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization
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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04055207062890PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
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04042761083485OlympusOLYMPUS Winter & Ibe GmbHGCM2020-07-31
04042761083492OlympusOLYMPUS Winter & Ibe GmbHGCM2020-07-31
00842180136014ELMEDELMED INCORPORATEDGCM2019-04-30
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00842180135956ELMEDELMED INCORPORATEDGCM2019-04-15
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04055207011652NARichard Wolf GmbHGCM2017-07-21
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