FDA UDI
In Commercial Distribution
🇺🇸 United States
CROMA Electrosurgical Generator
DI: 05060359561183
·
Model: 7-EMR-050 V6.001
·
CREO MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CROMA Electrosurgical Generator
- Primary DI
- 05060359561183
- Version / Model
- 7-EMR-050 V6.001
- Catalog Number
- 7-EMR-050
- Company Name
- CREO MEDICAL LIMITED
- Labeler DUNS
- 733853373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-08
- Public Version
- 2
- Public Version Date
- 2026-04-20
- Public Version Status
- Update
- Public Device Record Key
- 5de9375c-97cb-40d6-9696-886c9448899b
Device Description
The Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63396 | Microwave/electrosurgical system generator | An electrically-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 inert gas-enhanced electrosurgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060359561183 | GS1 | ||||
| Package | 05060359561190 | GS1 | Carton | 1 | In Commercial Distribution | |
| Previous | 05060359560513 | GS1 |
Customer Contacts
- Phone
- +18662261170
- [email protected]
- Phone
- +441291637300
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 69 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius