Identity
- Trade Name
- Ultima Stabilizer FDA UDI
- Generic Name
- Coronary artery exposure retractor FDA UDI
- Device Name
- Ultima OPCAB System FDA UDI
- Model / Reference
- OM-2001S FDA UDI
- Description
- Ultima OPCAB System FDA UDI
Identifiers
- Catalog Number
- OM-2001S FDA UDI
- Primary DI / UDI-DI
- 00607567700499 FDA UDI
- FDA Product Code
- MWS FDA UDI
- GMDN Term
- Coronary artery exposure retractor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 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
Yes
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: Coronary artery exposure retractor
Ultima Stabilizer by Maquet Cardiovascular LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coronary artery exposure retractor.
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- Assistant with StableSoft™ 3S Flex — Terumo Cardiovascular Systems Corporation · Class I
- Titan Flex 360 Stabilizer — Terumo Cardiovascular Systems Corporation · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- Intra-Art Coronary Artery Retraction Clip — GENESEE BIOMEDICAL, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Maquet Cardiovascular LLC
Sources (1)
- FDA UDI 4bc83c3e-dc76-46d9-a95e-d98a9c0ead13 35 fields · synced Jun 8, 2026