Tech Medical Services

FDA UDI

Class II (US FDA UDI)

by Tech Medical Services, Inc.

Identity

Trade Name: Tech Medical Services FDA UDI
Generic Name: Surgical irrigation/aspiration tubing set FDA UDI
Device Name: Disposable Suction Irrigation Probe, 5mm/45cm FDA UDI
Model / Reference: TMDSIP545 FDA UDI
Description: Disposable Suction Irrigation Probe, 5mm/45cm FDA UDI

Identifiers

Primary DI / UDI-DI: 00851695005081 FDA UDI
510(k) Number: K103509 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Surgical irrigation/aspiration tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical irrigation/aspiration tubing set

Tech Medical Services by Tech Medical Services, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation/aspiration tubing set.

LAMIS Tubing — Mentor Texas LP · Class I
Aspiration Tubing — BLACK & BLACK SURGICAL, INC. · Class II
MB ULTRA-LIMP TUBING — The Wells Johnson Company · Class II
INFILTRATION TUBING — BLACK & BLACK SURGICAL, INC. · Class II
Autofuse Tubing — Mentor Texas LP · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class II
ENDOFLOW II - PROBES - 4 holes diam.5 inch — Promepla · Class I
Hysteroscopy set 2 spikes — Promepla · Class II

Cleared under the same submission

K103509 also covers:

Tech Medical Services — TECH MEDICAL SERVICES, INC.

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 II	Pending data

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

Manufacturer

Manufacturer: Tech Medical Services, Inc.

Sources (1)

FDA UDI 20825095-8749-46f0-904f-a820eb36928f 34 fields · synced May 30, 2026