FDA.reportPublic FDA data

NA

Primary DI
04055207008843
Brand
NA
Company
Richard Wolf GmbH
Model
802015
Catalog number
8020.15
Device description
UNIVERSAL CAP FOR BRONCH. reusable
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTIBRONCHOSCOPE ACCESSORY
LLOLASER, NEODYMIUM:YAG, PULMONARY SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTIBronchoscope AccessoryEar, Nose, Throat2
LLOLaser, Neodymium:Yag, Pulmonary SurgeryEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207008843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207008843040552070088434055207008843

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope assembly adaptorA connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.

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
DM exempt
false
Premarket exempt
false
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860009430235Adapter SRA-1-01 SERPEX MEDICAL INC.KTI2025-12-08
10860009430249Adapter SRA-2-01 SERPEX MEDICAL INC.KTI2025-12-08
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
06934184007101MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007118MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007125MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007132MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007149MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007156MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007163MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007170MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007187MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007194MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007200MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007217MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
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