Identity
- Trade Name
- Epidural Disposable Box FDA UDI
- Generic Name
- Electronic epidural space locator pressure-sensing set FDA UDI
- Device Name
- Epidural Disposable Box of 10 units FDA UDI
- Model / Reference
- EPI-6100-01 FDA UDI
- Description
- Epidural Disposable Box of 10 units FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00618874610012 FDA UDI
- 510(k) Number
- K161883 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Electronic epidural space locator pressure-sensing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
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: Electronic epidural space locator pressure-sensing set
Epidural Disposable Box by Milestone Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electronic epidural space locator pressure-sensing set.
- Epidural Disposable Kit — MILESTONE SCIENTIFIC, INC. · Class II
- Epidural Disposable Kit — MILESTONE SCIENTIFIC, INC. · Class II
- Epidural Disposable Kit — MILESTONE SCIENTIFIC, INC. · Class II
- Epidural Disposable Kit — MILESTONE SCIENTIFIC, INC. · Class II
- Epidural Trainer Disposable Kit — MILESTONE SCIENTIFIC, INC. · Class II
Cleared under the same submission
K161883 also covers:
- CompuFlo Epidural — MILESTONE SCIENTIFIC, INC.
- CompuFlo Epidural Computer Controlled Anesthesia System — MILESTONE SCIENTIFIC, INC.
- CompuFlo Epidural Computer Controlled Anesthesia System — MILESTONE SCIENTIFIC, INC.
- Epidural Disposable Kit — MILESTONE SCIENTIFIC, INC.
- Epidural Disposable Kit — MILESTONE SCIENTIFIC, INC.
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
- Milestone Scientific, Inc.
Sources (1)
- FDA UDI b9212c68-0bb7-4852-b4a1-311d0a59e70b 34 fields · synced Jun 8, 2026