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ColpotomizOR Tube System

FDA UDI

Class II (US FDA UDI)

by Surgi Supplies International Pty. Ltd.

Identity

Trade Name
ColpotomizOR Tube System FDA UDI
Generic Name
Uterine manipulator, single-use FDA UDI
Device Name
45mm diameter trans-vaginal tube and uterine manipulator FDA UDI
Model / Reference
45mm FDA UDI
Description
45mm diameter trans-vaginal tube and uterine manipulator FDA UDI

Identifiers

Catalog Number
CTS45-TV FDA UDI
Primary DI / UDI-DI
09349967000335 FDA UDI
FDA Product Code
LKF FDA UDI
HEW FDA UDI
GMDN Term
Uterine manipulator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4530 FDA UDI
884.1640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Dimensions & Sizes

Size
Outer Diameter — 45 Millimeter FDA UDI

Category: Uterine manipulator, single-useColpotomy tube

ColpotomizOR Tube System by Surgi Supplies International Pty. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Colpotomy tube.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgi Supplies International Pty. Ltd.

Sources (1)

  • FDA UDI 41f57e3b-2200-4133-bc33-edbedb6dfce9 35 fields · synced Jun 8, 2026