Identity
- Trade Name
- Chalgren FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- Low Profile Needle Electrode, EEG, 12mm x 28g FDA UDI
- Model / Reference
- 112-812-48BTP FDA UDI
- Description
- Low Profile Needle Electrode, EEG, 12mm x 28g FDA UDI
Identifiers
- Catalog Number
- 112-812-48BTP FDA UDI
- Primary DI / UDI-DI
- 00816020020207 FDA UDI
- FDA Product Code
- GXZ FDA UDI
- GMDN Term
- Subdermal needle electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 28 Gauge FDA UDI
Category: Subdermal needle electrode
Chalgren by Chalgren Enterprises, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Chalgren Enterprises, Inc.
Sources (1)
- FDA UDI 20c8d2c1-cc3a-4628-b508-34fa6fe7c1e8 36 fields · synced May 31, 2026