← Back to catalogue

Eclipse

FDA UDI

Class II (US FDA UDI)

by Clinical Innovations, LLC

Identity

Trade Name
Eclipse FDA UDI
Generic Name
Faecal-incontinence vaginal insert pump FDA UDI
Device Name
Regulator FDA UDI
Model / Reference
RR02 FDA UDI
Description
Regulator FDA UDI

Identifiers

Catalog Number
RR02-MedHi FDA UDI
Primary DI / UDI-DI
00815430020562 FDA UDI
510(k) Number
K150558 FDA UDI
FDA Product Code
PJH FDA UDI
GMDN Term
Faecal-incontinence vaginal insert pump FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5930 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Faecal-incontinence vaginal insert pump

Eclipse by Clinical Innovations, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Faecal-incontinence vaginal insert pump.

Cleared under the same submission

K150558 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Clinical Innovations, LLC

Sources (1)

  • FDA UDI 976b833a-ca8c-46d1-9dd2-5b7f70c4369d 36 fields · synced Jun 9, 2026