FDA UDI
In Commercial Distribution
🇺🇸 United States
NICO Myriad
DI: 00816744028145
·
Model: NN-8014
·
NICO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NICO Myriad
- Primary DI
- 00816744028145
- Version / Model
- NN-8014
- Company Name
- NICO CORPORATION
- Labeler DUNS
- 829838288
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 3
- Public Version Date
- 2018-10-08
- Public Version Status
- Update
- Public Device Record Key
- b64af725-e146-498c-b71a-365df9f8a445
Device Description
Handpiece Universal Bending Tool
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63211 | Surgical probe/cannula bending tool | A sterile non-powered device designed to assist in the manual bending of a surgical handpiece tip, probe, or cannula to adjust the shape of the surgical device during surgery. It consists of a curved mould with a channel(s) to accept the surgical device and enable controlled manual bending. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816744028142 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00816744028145 | GS1 |
Customer Contacts
- Phone
- 317-660-7118
- [email protected]