FDA.report

NA

Primary DI
04055207013557
Brand
NA
Company
Richard Wolf GmbH
Model
7265001
Catalog number
7265.001
Device description
FIBER-BRONCHOSCOPE Ø 5MM WL 600MM flexible, working channel Ø 2.5mm, slanted distal tip, TL 860mm, deflection +130°/-130°, with suction valve, glass
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
EOQBRONCHOSCOPE (FLEXIBLE OR RIGID)
HRXArthroscope

Product Code Classifications

CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207013557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207013557040552070135574055207013557

GMDN Terms

TermDefinition
Flexible fibreoptic bronchoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device.

Device Sizes

TypeValueUnit
Length600Millimeter
Outer Diameter5Millimeter

Sterilization Methods

Method
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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