FDA.reportPublic FDA data

NA

Primary DI
04250480107614
Brand
NA
Company
SCHÖLLY FIBEROPTIC GmbH
Model
95-3910
Device description
Controller Full HD
Published
2019-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
FWFCamera, Television, Endoscopic, Without Audio
GJCAssay, Sulfhemoglobin
OWNConfocal Optical Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
FWFCamera, Television, Endoscopic, Without AudioGeneral, Plastic Surgery1
GJCAssay, SulfhemoglobinHematology2
OWNConfocal Optical ImagingGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250480107614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250480107614042504801076144250480107614

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

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
04250480104262N/A05-0762nir2025-06-11
04250480103906NA41-0005a2025-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840432200063CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200117CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200308CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200315CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200322CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840319757987Hayden MedicalHayden Medical, Inc.FWF2026-04-23
00840319758984Hayden MedicalHayden Medical, Inc.FWF2026-04-22
00840319758991Hayden MedicalHayden Medical, Inc.FWF2026-04-22
04048551418123n.a.Karl Storz GmbH & Co. KGFET2025-08-11
04250480104200NASCHÖLLY FIBEROPTIC GmbHOWN2025-06-11
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04048551411704NAKarl Storz GmbH & Co. KGOWN2025-03-27
08051887043286THD DIGITAL MINICAMTHD SPAFWF2025-02-20
04048551425695n.a.Karl Storz GmbH & Co. KGFET2024-12-20
04250480101704NASCHÖLLY FIBEROPTIC GmbHFET2024-12-03
04048551436271n.a.Karl Storz GmbH & Co. KGFET2024-11-28
04048551436271n.a.Karl Storz GmbH & Co. KGOWN2024-11-28
10884521816725VS3-IRVISIONSENSE LTD.OWN2024-11-11
04048551436240n.a.Karl Storz GmbH & Co. KGFET2024-10-18
04250480112861NASCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480112861NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
04250480112878NASCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480112878NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
04250480112885NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
04250480112885NASCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480113592NASCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480113592NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
04250480113608NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
04250480113608NASCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480113615NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08