Identity
- Trade Name
- ATAR R1 FDA UDI
- Generic Name
- Pacing/defibrillation lead electrical adaptor FDA UDI
- Device Name
- Reusable Extension Cable FDA UDI
- Model / Reference
- ATAR-R1 FDA UDI
- Description
- Reusable Extension Cable FDA UDI
Identifiers
- Catalog Number
- ATAR-R1 FDA UDI
- Primary DI / UDI-DI
- 00885672102654 FDA UDI
- 510(k) Number
- K070926 FDA UDI
- FDA Product Code
- IKD FDA UDI
- GMDN Term
- Pacing/defibrillation lead electrical adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 250 Centimeter FDA UDI
Atar R1 by Oscor Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K070926 also covers:
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
- Oscor Inc.
Sources (1)
- FDA UDI cc1afe74-009e-4048-bd93-351679c56345 39 fields · synced Jun 1, 2026