FDA UDI
In Commercial Distribution
🇺🇸 United States
NICO Myriad
DI: 00816744029029
·
Model: NN-9002
·
NICO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NICO Myriad
- Primary DI
- 00816744029029
- Version / Model
- NN-9002
- 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
- 58c8e020-75c9-4ade-92e2-09491eb13324
Device Description
Specimen Collector with Filter Element - Clamshell
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
- Yes
- 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 |
|---|---|---|---|---|
| FMH | Container, Specimen, Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62059 | Suction system filter, tissue, sterile | A sterile device intended to be fitted into a suction system bottle/canister to separate tissue from the aspirate during a surgical procedure; the tissue may be subsequently used for various diagnostic/therapeutic purposes (e.g., autologous fat tissue transfer, histological/pathological analysis). It is a meshed flat or tubular piece; accessory components (e.g., container sealing rings, tubing, filter housing) may be included. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816744029026 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00816744029029 | GS1 |
Customer Contacts
- Phone
- 317-660-7118
- [email protected]