FDA.reportPublic FDA data

RZ Medizintechnik GmbH

Primary DI
04049197401654
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
300-001-800
Catalog number
300-001-800
Device description
HD Digital Camera System F 3
Published
2024-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWFCAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWFCamera, Television, Endoscopic, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049197401654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049197401654040491974016544049197401654

GMDN Terms#

Term, Definition table
TermDefinition
Camera control unitA mains electricity (AC-powered) unit intended to be used to remotely steer a camera's movements and adjustments (e.g., a miniaturized camera) in a clinical setting. It is typically situated outside the field of operation and can be adjusted upon instructions from the surgeon/operator, or it may be automated to a certain degree. Some remote control units may have extensive functions and may supply the camera with electric current and adjustments such as light intensity, colour control, automatic exposure, and automatic flash. Those types used in ophthalmology may operate the raise/lower function of the ophthalmic instrument table upon which the camera is situated.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49746294700info@rz-medizintechnik.com

Regulatory Flags#

DUNS number
312953227
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049197177603RZ Medizintechnik GmbH253-000-097253-000-0972025-09-22
04049197393393RZ Medizintechnik GmbH253-000-084253-000-0842025-09-22
04049197495325RZ Medizintechnik GmbH253-000-320253-000-3202025-09-22
04049197495387RZ Medizintechnik GmbH253-000-332253-000-3322025-09-22
04049197177368RZ Medizintechnik GmbH253-000-044253-000-0442025-07-30
04049197177467RZ Medizintechnik GmbH253-000-047253-000-0472025-07-30
04049197177580RZ Medizintechnik GmbH253-000-094253-000-0942025-07-30
04049197177801RZ Medizintechnik GmbH253-000-200253-000-2002025-07-30
04049197178082RZ Medizintechnik GmbH253-000-201253-000-2012025-07-30
04049197178150RZ Medizintechnik GmbH253-000-210253-000-2102025-07-30
04049197178167RZ Medizintechnik GmbH253-000-211253-000-2112025-07-30
04049197178501RZ Medizintechnik GmbH253-000-258253-000-2582025-07-30
04049197178563RZ Medizintechnik GmbH253-000-352253-000-3522025-07-30
04049197178570RZ Medizintechnik GmbH253-000-356253-000-3562025-07-30
04049197178723RZ Medizintechnik GmbH253-000-358253-000-3582025-07-30
04049197178730RZ Medizintechnik GmbH253-000-366253-000-3662025-07-30
04049197178747RZ Medizintechnik GmbH253-000-368253-000-3682025-07-30
04049197178822RZ Medizintechnik GmbH253-000-524253-000-5242025-07-30
04049197178839RZ Medizintechnik GmbH253-000-527253-000-5272025-07-30
04049197178846RZ Medizintechnik GmbH253-000-552253-000-5522025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2025-09-25
B366U1VI2512R01PROCAM HD BASICEclerisFWF2025-08-22
00840319757994Hayden MedicalHayden Medical, Inc.FWF2025-04-30
00840319757949Hayden MedicalHayden Medical, Inc.FWF2025-04-11
00840319757956Hayden MedicalHayden Medical, Inc.FWF2025-04-11
04048551061343NAKarl Storz GmbH & Co. KGFWF2025-03-28
18051887043283THD DIGITAL MINICAMTHD SPAFWF2025-02-20
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2025-01-09
00848657077071AED ENDOPRO 3DNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2025-01-08
04049197151634RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-10-16
04049197223270RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-09-20
04049197223287RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-09-20
04049197505604RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2024-07-15
00848657076920ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2024-06-11
00848657076937ENDOPRO-MDTKNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2024-06-11
00840319756966Hayden MedicalHayden Medical, Inc.FWF2024-04-12
04049047668640NAGimmi GmbHFWF2023-05-03
B366HC2202PROCAM EclerisFWF2023-04-04
04049047669692GimmiGimmi GmbHFWF2023-02-14
04260744830561Fibre optic cableJoimax GmbHFWF2022-12-30
04260744831865Fibre optic cableJoimax GmbHFWF2022-12-30
B366U1HC112G22 PROCAM HD BASICEclerisFWF2022-09-07
B366U1VI2512PROCAM HD BASICEclerisFWF2022-09-07
B366HC2201PROCAM EclerisFWF2022-08-03
B366U1VI2511PROCAM Basic PALEclerisFWF2022-06-30
B366U1VI3111PROCAM FULL PALEclerisFWF2022-06-30
B366HC220PROCAM SDEclerisFWF2022-06-27
B366U1HC112G21 PROCAM SDEclerisFWF2022-06-27
10845854030059NAConmed CorporationFWF2021-12-15