Croma 7-EMR-050
GUDID 05060359560292
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator Microwave/electrosurgical system generator| Primary Device ID | 05060359560292 |
| NIH Device Record Key | 1ce3d83a-6387-4ff6-a0af-c8b8767da7ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Croma |
| Version Model Number | Croma Generator V4.0 |
| Catalog Number | 7-EMR-050 |
| Company DUNS | 733853373 |
| Company Name | CREO MEDICAL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060359560124 [Previous] |
| GS1 | 05060359560292 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171983
FDA Product Code
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-23 |
| Device Publish Date | 2021-03-15 |
On-Brand Devices [Croma]
| 05060359560070 | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed |
| 05060359560223 | A flexible, invasive, hand-held endoscopic device assembly intended to deliver microwave energy |
| 05060359560292 | A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical syste |
Trademark Results [Croma]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CROMA 98422206 not registered Live/Pending |
Jiangxi Xirui Manufacturing Co., Ltd. 2024-02-26 |
 CROMA 87855165 5829703 Live/Registered |
Madison Li Studio 2018-03-29 |
 CROMA 85449449 4269398 Live/Registered |
KNITPRO INTERNATIONAL 2011-10-18 |
 CROMA 78136725 2693576 Dead/Cancelled |
Croma, S.A.R.L 2002-06-18 |
 CROMA 77187430 4262844 Dead/Cancelled |
Fiat Group Automobiles S.p.A. 2007-05-22 |
 CROMA 76263412 not registered Dead/Abandoned |
VIVA TIME CORP. 2001-05-25 |
 CROMA 75982377 2613201 Live/Registered |
Feintechnik GmbH Eisfeld 1999-11-08 |
 CROMA 75844629 2878119 Dead/Cancelled |
Feintechnik GmbH Eisfeld 1999-11-08 |
 CROMA 75220712 not registered Dead/Abandoned |
CROMA (SaRL) 1997-01-02 |
 CROMA 75025009 2136544 Live/Registered |
HANSGROHE SE 1995-11-28 |
 CROMA 73840138 1624651 Dead/Cancelled |
BIEN-AIR S.A. 1989-11-15 |
 CROMA 73785160 1566011 Dead/Cancelled |
GILLETTE CANADA INC. 1989-03-07 |
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