FDA UDI
In Commercial Distribution
🇺🇸 United States
NICO Myriad NOVUS
DI: 00816744027704
·
Model: NN-7070
·
NICO CORPORATION
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NICO Myriad NOVUS
- Primary DI
- 00816744027704
- Version / Model
- NN-7070
- Company Name
- NICO CORPORATION
- Labeler DUNS
- 829838288
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-28
- Public Version
- 1
- Public Version Date
- 2023-05-08
- Public Version Status
- New
- Public Device Record Key
- 5c81a078-5578-4094-8d9a-ddc690536915
Device Description
Kit - US Analog
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Ear, Nose, Throat | 874.4250 | 2 |
| FST | Light, Surgical, Fiberoptic | General, Plastic Surgery | 878.4580 | 2 |
| HBC | Motor, Drill, Electric | Neurology | 882.4360 | 2 |
| HBI | Illuminator, Fiberoptic, Surgical Field | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46729 | Tissue morcellation system | An assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch; some designs may also provide suction intended for removal of resected tissue. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816744027704 | GS1 |
Customer Contacts
- Phone
- 317-660-7118
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191599 | 000 |