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Epidural Trainer Disposable Kit

FDA UDI

Class II (US FDA UDI)

by Milestone Scientific, Inc.

Identity

Trade Name
Epidural Trainer Disposable Kit FDA UDI
Generic Name
Electronic epidural space locator pressure-sensing set FDA UDI
Device Name
EPI 6510T CompuFlo Epidural Trainer Disposable Kit FDA UDI
Model / Reference
EPI-6510T FDA UDI
Description
EPI 6510T CompuFlo Epidural Trainer Disposable Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00618874999988 FDA UDI
510(k) Number
K053554 FDA UDI
FDA Product Code
FRN FDA UDI
GMDN Term
Electronic epidural space locator pressure-sensing set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 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 Trainer Disposable Kit 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.

Cleared under the same submission

K053554 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Milestone Scientific, Inc.

Sources (1)

  • FDA UDI dd78a604-c25c-4d3b-a359-3b4caea3aa11 34 fields · synced May 31, 2026