FDA.report

NA

Primary DI
04055207033494
Brand
NA
Company
Richard Wolf GmbH
Model
825103016
Catalog number
82510.3016
Device description
BRONCHOSCOPE-TUBE ID 3.2MM by Nicolai-Mantel, OD 3.8mm, TL 160mm, without proximal light connection, without distal viewing window, reusable
Published
2016-09-26
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
KTIBRONCHOSCOPE ACCESSORY

Product Code Classifications

CodeDeviceSpecialtyClass
KTIBronchoscope AccessoryEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207033494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207033494040552070334944055207033494

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
Lumen/Inner Diameter3.2Millimeter

Sterilization Methods

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

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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