FDA UDI
In Commercial Distribution
🇺🇸 United States
Minitouch
DI: 00850044503155
·
Model: 4006
·
Microcube, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Minitouch
- Primary DI
- 00850044503155
- Version / Model
- 4006
- Company Name
- Microcube, LLC
- Labeler DUNS
- 615286320
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-18
- Public Version
- 1
- Public Version Date
- 2023-10-26
- Public Version Status
- New
- Public Device Record Key
- 8c0a8ed8-37e2-4c5e-94b5-eb35351ed0d8
Device Description
Power Cord
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| MNB | Device, Thermal Ablation, Endometrial | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66977 | Microwave ablation system | An assembly of devices intended to generate and administer microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. It consists of an electrically-powered microwave energy generator, a user interface, and controls; a microwave ablation probe (not included) is used for energy application to the target area. It is intended to be used in percutaneous, laparoscopic, natural orifice or open surgery procedures to ablate tissue typically in the liver, lung, pancreas, kidney, and uterus (e.g., endometrial ablation). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850044503155 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P230002 | 000 |