FDA.report

NA

Primary DI
04055207017500
Brand
NA
Company
Richard Wolf GmbH
Model
8475031
Catalog number
8475.031
Device description
SUCT./IRRIG. TUBE OD 6.2MM WL 128MM for use with suction-irrigation handle 8475.26 and telescopes 8880.541 and 8880.543, straight, reusable
Published
2016-09-28
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
EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications

CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207017500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207017500040552070175004055207017500

GMDN Terms

TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.

Device Sizes

TypeValueUnit
Length128Millimeter
Outer Diameter6.2Millimeter

Sterilization Methods

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

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
true
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 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 DIBrandCompanyProduct codePublished
00850042909003ProsidioProsidio LLCEOB2026-01-16
00850042909010ProsidioProsidio LLCEOB2026-01-16
00850042909812ProsidioProsidio LLCEOB2026-01-16
00848657076883AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657076890AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657077712AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657078139AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657078146AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
04961333255191VIVIDEOHOYA CORPORATIONEOB2025-12-19
04961333255245VIVIDEOHOYA CORPORATIONEOB2025-12-19
00850042909027ProsidioProsidio LLCEOB2025-12-05
00850042909034ProsidioProsidio LLCEOB2025-12-05
00850042909041ProsidioProsidio LLCEOB2025-12-05
00850042909058ProsidioProsidio LLCEOB2025-12-05
00850042909065ProsidioProsidio LLCEOB2025-12-05
00850042909072ProsidioProsidio LLCEOB2025-12-05
00850042909089ProsidioProsidio LLCEOB2025-12-05
00850042909096ProsidioProsidio LLCEOB2025-12-05
00850042909102ProsidioProsidio LLCEOB2025-12-05
00850042909119ProsidioProsidio LLCEOB2025-12-05
00850042909126ProsidioProsidio LLCEOB2025-12-05
00850042909133ProsidioProsidio LLCEOB2025-12-05
00850042909140ProsidioProsidio LLCEOB2025-12-05
00850042909157ProsidioProsidio LLCEOB2025-12-05
00850042909164ProsidioProsidio LLCEOB2025-12-05
00850042909171ProsidioProsidio LLCEOB2025-12-05
00850042909188ProsidioProsidio LLCEOB2025-12-05
00850042909195ProsidioProsidio LLCEOB2025-12-05
00850042909201ProsidioProsidio LLCEOB2025-12-05
00850042909829ProsidioProsidio LLCEOB2025-12-05