FDA.report

NA

Primary DI
00814334021576
Brand
NA
Company
Richard Wolf GmbH
Model
8585072
Catalog number
8585.072
Device description
UNIVERSAL TRAY METAL reusable
Published
2018-03-05
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
FEBAccessories, cleaning, for endoscope

Product Code Classifications

CodeDeviceSpecialtyClass
FEBAccessories, Cleaning, For EndoscopeGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00814334021576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00814334021576008143340215768143340215760814334021576

GMDN Terms

TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

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
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 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
10724995245969Rapicide PA High-Level DisinfectantMEDIVATORS INC.FEB2026-03-06
40677964055322Medivators HookupMEDIVATORS INC.FEB2025-06-10
40677964054448Medivators HookupMEDIVATORS INC.FEB2025-04-04
40677964054622Medivators HookupMEDIVATORS INC.FEB2025-04-04
00860010835241System 83 RevolveWassenburg Medical, Inc.FEB2025-02-24
04260306710577SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
04260306710584SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
10705037069316EvotechADVANCED STERILIZATION PRODUCTS SERVICES INC.FEB2024-06-20
00724995225209NASTERIS CORPORATIONFEB2024-06-03
00724995225216NASTERIS CORPORATIONFEB2024-06-03
00724995225223NASTERIS CORPORATIONFEB2024-06-03
00724995225230NASTERIS CORPORATIONFEB2024-06-03
00724995225247NASTERIS CORPORATIONFEB2024-06-03
00724995225254NASTERIS CORPORATIONFEB2024-06-03
00724995225261NASTERIS CORPORATIONFEB2024-06-03
00724995225278NASTERIS CORPORATIONFEB2024-06-03
00724995225285NASTERIS CORPORATIONFEB2024-06-03
00724995225292NASTERIS CORPORATIONFEB2024-06-03
00724995225308NASTERIS CORPORATIONFEB2024-06-03
00724995225315NASTERIS CORPORATIONFEB2024-06-03
00724995225322NASTERIS CORPORATIONFEB2024-06-03
00724995225339NASTERIS CORPORATIONFEB2024-06-03
00724995225346NASTERIS CORPORATIONFEB2024-06-03
00724995225353NASTERIS CORPORATIONFEB2024-06-03
00724995225360NASTERIS CORPORATIONFEB2024-06-03
00724995225377NASTERIS CORPORATIONFEB2024-06-03
00724995225384NASTERIS CORPORATIONFEB2024-06-03
00724995225391NASTERIS CORPORATIONFEB2024-06-03
00724995225407NASTERIS CORPORATIONFEB2024-06-03
00724995225414NASTERIS CORPORATIONFEB2024-06-03