FDA.reportPublic FDA data

NA

Primary DI
04055207033586
Brand
NA
Company
Richard Wolf GmbH
Model
825105025
Catalog number
82510.5025
Device description
BRONCHOSCOPE-TUBE ID 5.2MM by Nicolai-Mantel, OD 5.8mm, TL 250mm, without proximal light connection, without distal viewing window, reusable
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04055207033586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207033586040552070335864055207033586

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter5.2Millimeter

Sterilization Methods#

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

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23
04055207013823NA80611638061.1632016-09-23
04055207013830NA80612538061.2532016-09-23
04055207013854NA80613538061.3532016-09-23
04055207013861NA80613568061.3562016-09-23
04055207013878NA80614538061.4532016-09-23
04055207013885NA80614568061.4562016-09-23
04055207013892NA80614578061.4572016-09-23
04055207013908NA80618538061.8532016-09-23
04055207013922NA80622518062.2512016-09-23
04055207013939NA80623518062.3512016-09-23
04055207013946NA80624518062.4512016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009698453161Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453178Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453185Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453208Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453215Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453222Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453239Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453246Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453192Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-19
00860009430242Adapter SRA-2-01 SERPEX MEDICAL INC.KTI2025-12-08
00860009430211Compass Steerable NeedleSERPEX MEDICAL INC.KTI2025-12-08
00860009430235Adapter SRA-1-01 SERPEX MEDICAL INC.KTI2025-12-08
10860009430249Adapter SRA-2-01 SERPEX MEDICAL INC.KTI2025-12-08
00816734023518BullDog®DIVERSATEK HEALTHCARE, INC.KTI2025-12-05
10816734023515BullDog®DIVERSATEK HEALTHCARE, INC.KTI2025-12-05
00850081350002Ion Pouch FRPRAXIS MEDICAL LLCKTI2025-11-06
00850081350019Monarch Pouch BVPRAXIS MEDICAL LLCKTI2025-11-06
00850081350026Monarch Pouch FRPRAXIS MEDICAL LLCKTI2025-11-06
00850081350033Olympus Pouch BVPRAXIS MEDICAL LLCKTI2025-11-06
00850081350040Olympus Pouch FRPRAXIS MEDICAL LLCKTI2025-11-06
00860003935842EndoCorePRAXIS MEDICAL LLCKTI2025-11-06
00860003935859Ion Pouch BVPRAXIS MEDICAL LLCKTI2025-11-06
04953170458378Single Use Aspiration Needle NA-201SX-4021OLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
04953170458385Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
04953170458392Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
04953170458408Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
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