Identity
- Trade Name
- Sonata IUUS Probe Return Kit EUDAMEDSonata® Intrauterine Ultrasound Probe Return Kit FDA UDI
- Generic Name
- Specimen container mailer, non-insulated FDA UDI
- Device Name
- Sonata IUUS Probe Return Kit EUDAMED
- Model / Reference
- RTN-001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- RTN-001 FDA UDI
- Primary DI / UDI-DI
- 10817929020036 EUDAMEDFDA UDI
- Basic UDI-DI
- 081792902RTNKITNB EUDAMED
- Direct Marketing DI
- 10817929020036 EUDAMED
- 510(k) Number
- K173703 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z12080280 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Specimen container mailer, non-insulated FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sonata IUUS Probe Return Kit by Gynesonics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081792902RTNKITNB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gynesonics, Inc.
- EUDAMED SRN
- US-MF-000017044
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 47dde5c2-4638-45e3-83eb-e19ff493061e 61 fields · synced Jun 19, 2026
- FDA UDI 4db97bf0-ba97-4a47-8284-5d8c1bb3df1b 36 fields · synced May 24, 2026