Identity
- Trade Name
- ACS Diagnostics FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Wire Restraint, 1-43/4" Foam, Wet Gel 7/ pack, 700 per case FDA UDI
- Model / Reference
- 4105DEL7 FDA UDI
- Description
- Wire Restraint, 1-43/4" Foam, Wet Gel 7/ pack, 700 per case FDA UDI
Identifiers
- Catalog Number
- 4105DEL7 FDA UDI
- Primary DI / UDI-DI
- 00813150021968 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic electrode, single-use
ACS Diagnostics by Graphic Controls Acquisition Corp — 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
- Graphic Controls Acquisition Corp
Sources (1)
- FDA UDI 0bf02efa-c703-4ff9-a0c5-30e7520ae030 35 fields · synced Jun 8, 2026