Identity
- Trade Name
- EmbraceTM Electrodes Array (L) FDA UDI
- Generic Name
- Cardiotocography telemetric monitoring system FDA UDI
- Device Name
- Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit. FDA UDI
- Model / Reference
- FG0003(X) FDA UDI
- Description
- Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit. FDA UDI
Identifiers
- Catalog Number
- FG0003(X) FDA UDI
- Primary DI / UDI-DI
- 07290016406030 FDA UDI
- FDA Product Code
- OSP FDA UDIHGM FDA UDI
- GMDN Term
- Cardiotocography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2720 FDA UDI884.2740 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Dimensions & Sizes
- Size
- Width — 280 Millimeter FDA UDILength — 320 Millimeter FDA UDI
EmbraceTM Electrodes Array (L) by Ob Tools, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Ob Tools, Ltd.
Sources (1)
- FDA UDI 85fe8e45-dc46-42bf-af31-9fd78dbca6ba 38 fields · synced May 30, 2026