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Uterine Manipulator / Injector 4, 5mm

FDA UDI

Class II (US FDA UDI)

by Purple Surgical International Limited

Identity

Trade Name
Uterine Manipulator / Injector 4,5mm FDA UDI
Generic Name
Salpingographic catheter FDA UDI
Device Name
The Uterine manipulator/Injector both a Uterine Manipulator and a Uterine Injector with application in Diagnostic Laparoscopy, Minilaparotomy, Fertility Examinations and salpingoplastics. FDA UDI
Model / Reference
PS3111 FDA UDI
Description
The Uterine manipulator/Injector both a Uterine Manipulator and a Uterine Injector with application in Diagnostic Laparoscopy, Minilaparotomy, Fertility Examinations and salpingoplastics. FDA UDI

Identifiers

Catalog Number
PS3111 FDA UDI
Primary DI / UDI-DI
05051223000600 FDA UDI
FDA Product Code
LKF FDA UDI
GMDN Term
Salpingographic catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4530 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

Category: Salpingographic catheter

Uterine Manipulator / Injector 4, 5mm by Purple Surgical International Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Salpingographic catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Purple Surgical International Limited

Sources (1)

  • FDA UDI 4e8a3d47-514f-4027-a04c-3b787e44b245 35 fields · synced May 30, 2026