FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Grass
DI: 00382830017282
·
Model: F-EPG-G-15CM-48
·
NATUS MANUFACTURING LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Grass
- Primary DI
- 00382830017282
- Version / Model
- F-EPG-G-15CM-48
- Company Name
- NATUS MANUFACTURING LIMITED
- Labeler DUNS
- 896421240
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-17
- Public Version
- 3
- Public Version Date
- 2020-09-15
- Public Version Status
- Update
- Public Device Record Key
- 817d8d47-0391-4858-ac5b-a46a7e375761
- Distribution End Date
- 2020-01-15
Device Description
Genuine GRASS Nasopharyngeal Electrodes15cm- Reusable
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11452 | Nasopharyngeal electrode | An electrical conductor intended to be temporarily placed in the nasopharyngeal region to record electrical activity. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382830017282 | GS1 |