← Back to catalogue

HSG Trays/Kits 7fr

FDA UDI

Class II (US FDA UDI)

by Titus Medical Llc

Identity

Trade Name
HSG Trays/Kits 7fr FDA UDI
Generic Name
Uterine injector FDA UDI
Device Name
Case of 10 HSG/SIS Trays/Kits with 7Fr catheter FDA UDI
Model / Reference
06-307 FDA UDI
Description
Case of 10 HSG/SIS Trays/Kits with 7Fr catheter FDA UDI

Identifiers

Primary DI / UDI-DI
10850011427153 FDA UDI
510(k) Number
K092969 FDA UDI
FDA Product Code
LKF FDA UDI
GMDN Term
Uterine injector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4530 FDA UDI
Commercial Distribution
Not 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

HSG Trays/Kits 7fr by Titus Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K092969 also covers:

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
Titus Medical Llc

Sources (1)

  • FDA UDI 25f93b75-41f6-4248-a3a0-bcd95b861827 36 fields · synced May 30, 2026