Identity
- Trade Name
- ATAR D-MDTS FDA UDI
- Generic Name
- Pacing/defibrillation lead electrical adaptor FDA UDI
- Device Name
- Disposable Extension Cable FDA UDI
- Model / Reference
- ATAR D-MDTS FDA UDI
- Description
- Disposable Extension Cable FDA UDI
Identifiers
- Catalog Number
- ATAR D-MDTS FDA UDI
- Primary DI / UDI-DI
- 10885672101944 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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 — 20 Centimeter FDA UDI
Category: Pacing/defibrillation lead electrical adaptor
Atar D-Mdts by Oscor Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pacing/defibrillation lead electrical adaptor.
- Lead Adapter — Greatbatch Ltd · Class II
- IS1-C5PS — BIOTRONIK SE & Co. KG · Class II
- Lead Adapter — Greatbatch Ltd · Class II
- Lead Adapter — Greatbatch Ltd · Class II
- Lead Adapter — Greatbatch Ltd · Class II
- Lead Adapter — Greatbatch Ltd · Class II
- SJM™ — ST. JUDE MEDICAL, INC. · Class III
- Cap and Sleeve Kit — Greatbatch Ltd · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oscor Inc.
Sources (1)
- FDA UDI 427920ac-75b8-4c9b-aec5-927b0e844364 38 fields · synced May 30, 2026