Identity
- Trade Name
- SPINAUT-S FDA UDI
- Generic Name
- Flexible fibreoptic epiduroscope FDA UDI
- Model / Reference
- MS0.4-7000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809317177953 FDA UDI
- 510(k) Number
- K151268 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Flexible fibreoptic epiduroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Flexible fibreoptic epiduroscope
Spinaut-S by Imedicom Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic epiduroscope.
- Clarus Flexible Fiberoptic Endoscope — CLARUS MEDICAL, LLC · Class II
- SPINAUT-S — IMEDICOM CO., LTD. · Class II
- SPINAUT-S — IMEDICOM CO., LTD. · Class II
Cleared under the same submission
K151268 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Imedicom Co., Ltd.
Sources (1)
- FDA UDI 1923173c-10b4-4efe-a3b9-71c0a0fca2ee 33 fields · synced May 30, 2026