Identity
- Trade Name
- Spark Imagine Create FDA UDI
- Generic Name
- Teething device, fluid-filled FDA UDI
- Device Name
- SCI - Small Gift Set Elephant FDA UDI
- Model / Reference
- 26019FB FDA UDI
- Description
- SCI - Small Gift Set Elephant FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00681131402682 FDA UDI
- FDA Product Code
- KKO FDA UDI
- GMDN Term
- Teething device, fluid-filled FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Teething device, fluid-filled
Spark Imagine Create by Sassy Baby, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Sassy Baby, Inc
Sources (1)
- FDA UDI 31ad3a5f-ef9f-4603-ab6f-9b9368e63c5f 33 fields · synced Jun 8, 2026