Identity
- Trade Name
- Shikani Antrostomy Stent FDA UDI
- Generic Name
- Nasal cavity stent, removable, prefabricated FDA UDI
- Model / Reference
- SP-80010 FDA UDI
Identifiers
- Catalog Number
- SP-80010 FDA UDI
- Primary DI / UDI-DI
- 00385640000178 FDA UDI
- FDA Product Code
- LYA FDA UDI
- GMDN Term
- Nasal cavity stent, removable, prefabricated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4780 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: Nasal cavity stent, removable, prefabricated
Shikani Antrostomy Stent by Summit Medical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal cavity stent, removable, prefabricated.
- Shikani Antrostomy Stent — Summit Medical, LLC · Class I
- Shikani Antrostomy Stent — Summit Medical, LLC · 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
- Summit Medical, LLC
Sources (1)
- FDA UDI 983a0753-47e5-42a2-af5f-6abe31ef6c4a 34 fields · synced Jun 1, 2026