FDA.reportPublic FDA data

NA

Primary DI
04055207009468
Brand
NA
Company
Richard Wolf GmbH
Model
825630
Catalog number
8256.30
Device description
ESOPHAGOSCOPE-TUBE ID 13.5X9.5MM model Wolf, OD 15.5x11.5mm, TL 444mm, with fixed distal light carrier, graduated, reusable
Published
2016-09-27
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
EOXESOPHAGOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOXEsophagoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207009468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207009468040552070094684055207009468

GMDN Terms#

Term, Definition table
TermDefinition
Rigid oesophagoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a reusable device.

Sterilization Methods#

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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551178515n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551178539n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551178546n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190098n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190104n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190111n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551001387n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551001493n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551001974n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047675n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047811n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047828n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047866n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047873n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047897n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047903n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047941n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047989n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047996n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551048641n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551048658n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551053591n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551068762n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551068786n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551069615n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551069639n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551069653n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551069677n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551069714n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551069738n.a.Karl Storz GmbH & Co. KGEOX2016-09-23