FDA.reportPublic FDA data

FENTEX

Primary DI
04250407762483
Brand
FENTEX
Company
FENTEX medical GmbH
Model
507028FX
Catalog number
507028FX
Device description
TV Adapter f=28mm, C-Mount, waterproof
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQMCAMERA, SURGICAL AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250407762483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407762483042504077624834250407762483

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope camera adaptorAn optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4974679496212s.renner@fentexmedical.com

Regulatory Flags#

DUNS number
507221724
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250407748814FENTEX711160FX711160FX2022-12-12
04250407748821FENTEX711161FX711161FX2022-12-12
04250407748838FENTEX711162FX711162FX2022-12-12
04250407748845FENTEX711166FX711166FX2022-12-12
04250407748852FENTEX711167FX711167FX2022-12-12
04250407749231FENTEX716500FX716500FX2022-12-12
04250407749255FENTEX716516FX716516FX2022-12-12
04250407749262FENTEX716549FX716549FX2022-12-12
04250407749279FENTEX716600FX716600FX2022-12-12
04250407749286FENTEX716700FX716700FX2022-12-12
04250407749293FENTEX716702FX716702FX2022-12-12
04250407749309FENTEX716703FX716703FX2022-12-12
04250407749316FENTEX716704FX716704FX2022-12-12
04250407753283FENTEX811160FX811160FX2022-12-12
04250407753788FENTEX816500FX816500FX2022-12-12
04250407753801FENTEX816600FX816600FX2022-12-12
04250407753825FENTEX816700FX816700FX2022-12-12
04250407753832FENTEX816702FX816702FX2022-12-12
04250407753849FENTEX816703FX816703FX2022-12-12
04250407753856FENTEX816704FX816704FX2022-12-12

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Primary DI, Brand, Company table
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00819761023094Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-04
05415334053168BarcoBarco NVKQM2026-06-02
05415334053335BarcoBarco NVKQM2026-06-02
05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
03700712434472Maquet OrchideMAQUET SASKQM2026-05-06
03700712434489Maquet OrchideMAQUET SASKQM2026-05-06
04548736183407SONYSONY CORPORATIONKQM2026-04-30
04548736183414SONYSONY CORPORATIONKQM2026-04-30
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
04548736155978SONYSONY CORPORATIONKQM2025-11-04
04548736155985SONYSONY CORPORATIONKQM2025-11-04
04548736169968SONYSONY CORPORATIONKQM2025-11-04
04548736169951SONYSONY CORPORATIONKQM2025-10-06
04548736155091SONYSONY CORPORATIONKQM2025-09-30
04548736155107SONYSONY CORPORATIONKQM2025-09-30
04548736170735SONYSONY CORPORATIONKQM2025-09-30
04548736170759SONYSONY CORPORATIONKQM2025-09-30
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170681SONYSONY CORPORATIONKQM2025-06-24
04548736170704SONYSONY CORPORATIONKQM2025-06-24
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09