← Back to catalogue

Endocervical Speculum

FDA UDI

Class I (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name
Endocervical Speculum FDA UDI
Generic Name
Manual expandable cervical dilator FDA UDI
Device Name
Endocervical Speculum - Screw/Knob handle: Tip size: Small- 3 mm; Length: 270 mm FDA UDI
Model / Reference
66-433 FDA UDI
Description
Endocervical Speculum - Screw/Knob handle: Tip size: Small- 3 mm; Length: 270 mm FDA UDI

Identifiers

Primary DI / UDI-DI
00888937018288 FDA UDI
FDA Product Code
GEN FDA UDI
GMDN Term
Manual expandable cervical dilator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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
Outer Diameter — 3 Millimeter FDA UDI
Length — 270 Millimeter FDA UDI

Category: Manual expandable cervical dilator

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

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

Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA UDI a90ab557-d354-4c99-9122-da2ee57a6462 34 fields · synced Jun 9, 2026