FDA.reportPublic FDA data

NA

Primary DI
04250480106174
Brand
NA
Company
SCHÖLLY FIBEROPTIC GmbH
Model
41.0665a
Device description
UMP-set (Ultra-Mini Nephroscope, Sheaths, Obturators, Cleaning Basket)
Published
2020-04-16
Public version status
New
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
04250480106174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250480106174042504801061744250480106174

GMDN Terms#

Term, Definition table
TermDefinition
Stone/foreign-body extraction setA collection of surgical instruments intended to remove calculi, debris, and/or to retrieve fragments of catheter tubing, wire guides, pull wires, plastic stents and other foreign bodies during urological and/or gastroenterological interventions. It typically consists of a retrieval basket and/or grasping forceps, an introducing sheath or sleeve, and possibly a guidewire; the exact design of the set will vary depending on the surgical method. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
316276682
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
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