Identity
- Trade Name
- Acrobat-i Positioner FDA UDI
- Generic Name
- Coronary artery exposure retractor FDA UDI
- Device Name
- Acrobat-i Vacuum Positioner System FDA UDI
- Model / Reference
- XP-5000 FDA UDI
- Description
- Acrobat-i Vacuum Positioner System FDA UDI
Identifiers
- Catalog Number
- XP-5000 FDA UDI
- Primary DI / UDI-DI
- 00607567700574 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
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: Coronary artery exposure retractor
Acrobat-i Positioner by Maquet Cardiovascular LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 113c2fa4-06ab-404d-b036-dc472d9bbb3c 35 fields · synced Jun 8, 2026