Identity
- Trade Name
- SPINAUT-E FDA UDI
- Generic Name
- Spinal infusion/drainage catheter FDA UDI
- Model / Reference
- E2100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809317177311 FDA UDI
- 510(k) Number
- K150789 FDA UDI
- FDA Product Code
- BSO FDA UDI
- GMDN Term
- Spinal infusion/drainage catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5120 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
Yes
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
Yes
FDA UDI
Category: Spinal infusion/drainage catheter
Spinaut-E by Imedicom Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal infusion/drainage catheter.
- Prometra Catheter Revision Kit — Flowonix Medical, Inc. · Class III
- Video Guided Catheter — Myelotec, Inc. · Class II
- Prometra Intrathecal Catheter — Flowonix Medical, Inc. · Class III
- Video Guided Catheter — Myelotec, Inc. · Class II
- NaviCath — Myelotec, Inc. · Class II
- SPINAUT-E — IMEDICOM CO., LTD. · Class II
- SPINAUT-E — IMEDICOM CO., LTD. · Class II
- SPINAUT-E — IMEDICOM CO., LTD. · Class II
Cleared under the same submission
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 b89b38ee-d5da-4183-8761-242ff724ae42 33 fields · synced May 30, 2026