FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroBlate Fine
DI: 05060359560971
·
Model: 7-NP1-100
·
CREO MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MicroBlate Fine
- Primary DI
- 05060359560971
- Version / Model
- 7-NP1-100
- Catalog Number
- 7-NP1-100
- Company Name
- CREO MEDICAL LIMITED
- Labeler DUNS
- 733853373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-05
- Public Version
- 1
- Public Version Date
- 2025-05-13
- Public Version Status
- New
- Public Device Record Key
- 72028893-3081-49e9-987d-e84c36a8e8ba
Device Description
MicroBlate Fine (NP1) is a single-use, sterile electrosurgical instrument for use with the Creo Medical Electrosurgical system. It enables ablation of potential malignant lesions such as nodules or tumors. MicroBlate Fine, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEY | System, Ablation, Microwave And Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61286 | Microwave ablation system probe, non-powered | A non-active, hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The probe includes a handle and a patient contact region (e.g., antenna, leaflets), and might include a cooling mechanism (via water irrigation). The device is intended to be used in percutaneous, endoscopic [e.g., gastroscopic, laparoscopic], natural orifice or open surgery procedures to ablate tissues (e.g., endometrial ablation). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060359560490 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 05060359560971 | GS1 | ||||
| Package | 05060359560483 | GS1 | Shipper 5-Up | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +18662261170
- [email protected]
- Phone
- +441291637300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221672 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1.9 | Meter | |
| Outer Diameter | 2.4 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 69 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 69 – 109 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius