FDA.reportPublic FDA data

NA

Primary DI
04250480106457
Brand
NA
Company
SCHÖLLY FIBEROPTIC GmbH
Model
7230002
Device description
Video Naso-Pharyngoscope Controller
Published
2016-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250480106457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250480106457042504801064574250480106457

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video imaging systemAn assembly of mains electricity (AC-powered) devices designed to obtain, transmit, and display video images during an endoscopic procedure. It typically consists of one or more video endoscopes, an endoscopic camera, camera control unit, light source with light cables, video recorder, imaging units with perhaps a colour compensation device, a distention unit, and a visual display unit (VDU), all of which is typically placed/mounted onto a trolley (cart) that can be moved to different examination/treatment rooms.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250480104200NA95-39092025-06-11
04250480104262N/A05-0762nir2025-06-11
04250480103906NA41-0005a2025-04-09
04250480100271NA05.0100z2025-01-15
04250480100288NA05.0101o2025-01-15
04250480100295NA05.0102b2025-01-15
04250480100325NA05.0106c2025-01-15
04250480100349NA05.0108z2025-01-15
04250480100356NA05.0110b2025-01-15
04250480100363NA05.0112c2025-01-15
04250480101759NARL-1002025-01-15
04250480101766NARL-1302025-01-15
04250480101773NARL-1452025-01-15
04250480101780NARL-5002025-01-15
04250480101797NARL-5302025-01-15
04250480101704NAVP-7000X2024-12-03
04250480101711NASC-7000X2024-12-03
04250480101728NALG-7000X2024-12-03
04250480101735NAAL-7000X 2024-12-03
04250480112809NA05.0085l.ht2024-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850042909003ProsidioProsidio LLCEOB2026-01-16
00850042909010ProsidioProsidio LLCEOB2026-01-16
00850042909812ProsidioProsidio LLCEOB2026-01-16
00848657076883AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657076890AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657077712AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657078139AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657078146AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
04961333255191VIVIDEOHOYA CORPORATIONEOB2025-12-19
04961333255245VIVIDEOHOYA CORPORATIONEOB2025-12-19
00850042909027ProsidioProsidio LLCEOB2025-12-05
00850042909034ProsidioProsidio LLCEOB2025-12-05
00850042909041ProsidioProsidio LLCEOB2025-12-05
00850042909058ProsidioProsidio LLCEOB2025-12-05
00850042909065ProsidioProsidio LLCEOB2025-12-05
00850042909072ProsidioProsidio LLCEOB2025-12-05
00850042909089ProsidioProsidio LLCEOB2025-12-05
00850042909096ProsidioProsidio LLCEOB2025-12-05
00850042909102ProsidioProsidio LLCEOB2025-12-05
00850042909119ProsidioProsidio LLCEOB2025-12-05
00850042909126ProsidioProsidio LLCEOB2025-12-05
00850042909133ProsidioProsidio LLCEOB2025-12-05
00850042909140ProsidioProsidio LLCEOB2025-12-05
00850042909157ProsidioProsidio LLCEOB2025-12-05
00850042909164ProsidioProsidio LLCEOB2025-12-05
00850042909171ProsidioProsidio LLCEOB2025-12-05
00850042909188ProsidioProsidio LLCEOB2025-12-05
00850042909195ProsidioProsidio LLCEOB2025-12-05
00850042909201ProsidioProsidio LLCEOB2025-12-05
00850042909829ProsidioProsidio LLCEOB2025-12-05