FDA.report

TEXAS

Primary DI
04055207033753
Brand
TEXAS
Company
Richard Wolf GmbH
Model
825200841
Catalog number
82520.0841
Device description
BRONCHOSCOPE-TUBE ID 11MM OD 13.2mm, TL 351mm, for use with the optical element 82510.1400 and head systems 825101100 and 825101200, with distal view
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
04055207033753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207033753040552070337534055207033753

GMDN Terms

TermDefinition
Bronchoscopy tubeA hollow cylinder composed of plastic, rubber, or other material that is inserted orally into the trachea to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation during diagnostic or therapeutic bronchoscopy using a flexible bronchoscope. It has a cuff at the distal end, similar to that of a cuffed endotracheal (ET) tube and may be packaged with a connector that attaches to a breathing circuit. It has a large enough bore to accommodate a flexible bronchoscope; this can enhance the safety of the procedure. This is a single-use device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter11Millimeter

Sterilization Methods

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