LEEP Jackson Retractor

FDA UDI

Class I (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: LEEP Jackson Retractor FDA UDI
Generic Name: Vaginal speculum, reusable FDA UDI
Device Name: LEEP Jackson Retractor - Coated- Large FDA UDI
Model / Reference: F234 FDA UDI
Description: LEEP Jackson Retractor - Coated- Large FDA UDI

Identifiers

Primary DI / UDI-DI: 00888937016178 FDA UDI
FDA Product Code: HDF FDA UDI
GMDN Term: Vaginal speculum, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.4520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 40 Millimeter FDA UDI
Length — 115 Millimeter FDA UDI

Category: Vaginal speculum, reusable

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

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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 I	Pending data

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Manufacturer

Manufacturer: CooperSurgical, Inc.

Sources (1)

FDA UDI 687de633-6843-40b6-8244-e7891d15000f 34 fields · synced Jun 9, 2026