FDA.reportPublic FDA data

NA

Primary DI
04250480106938
Brand
NA
Company
SCHÖLLY FIBEROPTIC GmbH
Model
41.0676a
Device description
UMP - Cleaning basket
Published
2020-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FECObturator, For Endoscope
FEDEndoscopic Access Overtube, Gastroenterology-Urology
FGAKit, Nephroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FECObturator, For EndoscopeGastroenterology, Urology2
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2
FGAKit, NephroscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250480106938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250480106938042504801069384250480106938

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999info@schoelly-usa.com

Regulatory Flags#

DUNS number
316276682
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250480112564NA05-0094l-nir2025-01-17
04250480101728NALG-7000X2024-12-03
04250480112809NA05.0085l.ht2024-01-08
04250480112816NA05.0087l2024-01-08
04250480112823NA05.0088l.ht2024-01-08
04250480112830NA05.0090l2024-01-08
04250480112847NA05.0090l.ht2024-01-08
04250480109038NA05-0094l-nir2023-10-30
04250480100202NA05.0084l2019-02-13
04250480100219NA05.0085l2019-02-13
04250480100226NA05.0086l2019-02-13
04250480100233NA05.0087l2019-02-13
04250480100240NA05.0088l2019-02-13
04250480100257NA05.0090l2019-02-13
04250480100264NA05.0090l.ht2019-02-13
04250480106914NA05.0085l.ht2019-02-13
04250480106976NA05.0088l.ht2019-02-13
04250480104200NA95-39092025-06-11
04250480104262N/A05-0762nir2025-06-11
04250480103906NA41-0005a2025-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936345101536Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345101543Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104469Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104476Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104483Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104490Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104544Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104551Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104568Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104575Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
10810068811114MONARCH™ Mini-PCNL Suction SetAuris Health, Inc.FGA2026-05-05
00860005357741CVAC Aspiration SystemCalyxo, Inc.FED2025-09-10
00810143891294Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
00860012876808Air AssistGASTRO CONCEPTS LLCFED2025-03-17
03600040995150ReTraceColoplast A/SFED2024-11-20
03600040995181ReTraceColoplast A/SFED2024-11-20
03600040995211ReTraceColoplast A/SFED2024-11-20
03600040995242ReTraceColoplast A/SFED2024-11-20
03600040995273ReTraceColoplast A/SFED2024-11-20
03600040995303ReTraceColoplast A/SFED2024-11-20
03600040995334ReTraceColoplast A/SFED2024-11-20
03600040995365ReTraceColoplast A/SFED2024-11-20
04055207038666NARichard Wolf GmbHFGA2024-04-01
00860005357710CVAC Aspiration SystemCalyxo, Inc.FED2024-02-22
15019778008653OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFED2023-10-30
15019778008660OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFED2023-10-30
15019778008677OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFED2023-10-30
15019778008684OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFED2023-10-30
10860006600805AncoraAspero Medical, Inc.FED2023-10-26
04547410484687FUJIFILMFUJIFILM CORPORATIONFED2023-10-23