FDA.reportPublic FDA data

TEXAS

Primary DI
04055207033791
Brand
TEXAS
Company
Richard Wolf GmbH
Model
825201441
Catalog number
82520.1441
Device description
TRACHEAL SCOPE-TUBE ID 17.1MM OD 19.3mm, TL 360mm, for use with the optical element 82510.1400 and head systems 825101100 and 825101200, with distal
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTIBRONCHOSCOPE ACCESSORY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTIBronchoscope AccessoryEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207033791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207033791040552070337914055207033791

GMDN Terms#

Term, Definition table
TermDefinition
Basic endotracheal tube, reusableA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter17.1Millimeter

Sterilization Methods#

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

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

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Primary DI, Brand, Company table
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10816734023515BullDog®DIVERSATEK HEALTHCARE, INC.KTI2025-12-05
14953170458375Single Use Aspiration Needle NA-201SX-4021OLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458382Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458399Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458405Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
44026704721151PILLINGTELEFLEX INCORPORATEDKTI2025-07-11
14953170458412DISPOSABLE GRASPING FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-05-14
06934184007088MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007095MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
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06934184007224MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007231MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007248MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007255MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007262MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007279MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10