Identity
- Trade Name
- A.M.I. Recto Anal Repair Probe FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system FDA UDI
- Model / Reference
- RAR 2011 FDA UDI
Identifiers
- Catalog Number
- RAR 2011 FDA UDI
- Primary DI / UDI-DI
- EAMIRAR20110 FDA UDI
- 510(k) Number
- K061831 FDA UDI
- FDA Product Code
- IYN FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
A.M.I. Recto Anal Repair Probe by AMI Agency for Medical Innovations GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- AMI Agency for Medical Innovations GmbH
Sources (1)
- FDA UDI dc638737-391e-4251-a880-9bf75757a00a 35 fields · synced May 31, 2026