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Eclipse

FDA UDI

Class II (US FDA UDI)

by Clinical Innovations, LLC

Identity

Trade Name
Eclipse FDA UDI
Generic Name
Faecal-incontinence vaginal insert sizer FDA UDI
Device Name
Sizer FDA UDI
Model / Reference
SZ02 FDA UDI
Description
Sizer FDA UDI

Identifiers

Catalog Number
SZ02-51RD FDA UDI
Primary DI / UDI-DI
00815430020418 FDA UDI
510(k) Number
K150558 FDA UDI
FDA Product Code
PJH FDA UDI
GMDN Term
Faecal-incontinence vaginal insert sizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5930 FDA UDI
Commercial Distribution
Not 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

Dimensions & Sizes

Size
Length — 51 Millimeter FDA UDI
Width — 51 Millimeter FDA UDI

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

Cleared under the same submission

K150558 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clinical Innovations, LLC

Sources (1)

  • FDA UDI 187ddede-730b-4c75-ba94-24d61e390afd 38 fields · synced Jun 9, 2026