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LEEP Endocervical Speculum

FDA UDI

Class I (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name
LEEP Endocervical Speculum FDA UDI
Generic Name
Manual expandable cervical dilator FDA UDI
Device Name
LEEP Endocervical Speculum - Coated- Medium FDA UDI
Model / Reference
F510 FDA UDI
Description
LEEP Endocervical Speculum - Coated- Medium FDA UDI

Identifiers

Primary DI / UDI-DI
00888937016253 FDA UDI
FDA Product Code
HFB FDA UDI
GMDN Term
Manual expandable cervical dilator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
884.4530 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Width — 5 Millimeter FDA UDI
Length — 273 Millimeter FDA UDI

Category: Manual expandable cervical dilator

LEEP Endocervical Speculum by CooperSurgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual expandable cervical dilator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA UDI a3823c09-1beb-4d26-bbcf-6878e8c99621 34 fields · synced Jun 9, 2026