FDA UDI
In Commercial Distribution
🇺🇸 United States
Nobilium
DI: M482D1EN0
·
Model: D1EN
·
CMP INDUSTRIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Nobilium
- Primary DI
- M482D1EN0
- Version / Model
- D1EN
- Company Name
- CMP INDUSTRIES LLC
- Labeler DUNS
- 002064319
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-16
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- e2c2fbf7-bdc5-44ab-98f3-721f425b32bd
Device Description
DENTURE ID MICROCHIP DENTURE ID MICROCHIP
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 Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| PYQ | Rfid Chip For Dental Appliance | General Hospital | 880.6300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60472 | Radio-frequency identification patient positioning/tracking system | An assembly of hardware/software devices intended to employ radio-frequency identification (RFID) techniques to aid in the correct identification and positioning of the patient during a diagnostic imaging, treatment planning or radiation therapy procedure. It typically consists of RFID tags worn by the patient or embedded/attached to treatment accessories, a RFID reader, optical markers and optical camera, monitor, and hand-held control unit; it may also use an infrared tracking camera and/or a video camera. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M482D1EN0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170423 | 000 |