FDA.reportPublic FDA data

N/A

Primary DI
04250480104262
Brand
N/A
Company
SCHÖLLY FIBEROPTIC GmbH
Model
05-0762nir
Device description
NIR FI+ Light Source
Published
2025-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCWLight Source, Fiberoptic, Routine
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCWLight Source, Fiberoptic, RoutineGastroenterology, Urology2
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250480104262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250480104262042504801042624250480104262

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source unit, line-poweredA mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

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
04250480103906NA41-0005a2025-04-09
04250480112519NA11-0131nir2025-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826921438PENTAX MedicalPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826927669PENTAX MedicalPENTAX MEDICAL CORPORATIONFCW2026-08-25
04580826927713PENTAX MedicalPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826930935INSPIRAPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826930959INSPIRAPENTAX MEDICAL CORPORATIONFET2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
17290016992158SOLO SCOPE Disposable ColonoscopeG.I. VIEW LTDFET2026-08-25
17290016992172SOLO SCOPE Video ControllerG.I. VIEW LTDFET2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21