Identity
- Trade Name
- Sonata Sterile Shipper Kit EUDAMEDSonata® IUUS Probe Sterile Shipper Kit FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- Sonata Sterile Shipper Kit EUDAMEDSterilization packaging, single use FDA UDI
- Model / Reference
- SHPR-001 EUDAMEDFDA UDI
- Description
- Sterilization packaging, single use FDA UDI
Identifiers
- Catalog Number
- SHPR-001 FDA UDI
- Primary DI / UDI-DI
- 10817929020135 EUDAMEDFDA UDI
- Basic UDI-DI
- 081792902STERPKMX EUDAMED
- Direct Marketing DI
- 10817929020135 EUDAMED
- 510(k) Number
- K173703 FDA UDI
- FDA Product Code
- KNF FDA UDIITX FDA UDI
- EMDN Code
- S0199 DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z) - OTHER EUDAMED
- GMDN Term
- Sterilization packaging, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4160 FDA UDI892.1570 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
No
FDA UDI
Sonata Sterile Shipper 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 | 081792902STERPKMX | 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 61b7a9c9-f5d5-42ba-bc3d-272bcb3d958e 61 fields · synced Jun 18, 2026
- FDA UDI 922466bf-74eb-4995-95ef-bbacf4d4f3da 37 fields · synced May 30, 2026