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 tissue/fluid collection bag FDA UDI
Device Name: Detachable Endo Pouch FDA UDI
Model / Reference: TM2002 FDA UDI
Description: Detachable Endo Pouch FDA UDI

Identifiers

Primary DI / UDI-DI: 00851695005111 FDA UDI
510(k) Number: K103510 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Surgical tissue/fluid collection bag 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

Yes

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

Sterilization Method

Ethylene Oxide FDA UDI

Category: Surgical tissue/fluid collection bag

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 tissue/fluid collection bag.

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Custom Medical Specialties, Inc. — CUSTOM ASSEMBLIES, INC. · Class I
SchureMed — SCHUERCH CORPORATION · Class I
Custom Medical Specialties, Inc. — CUSTOM ASSEMBLIES, INC. · Class I
Aveta Tissue Catch — Meditrina, Inc. · Class II
Medline-Microtek — Microtek Medical LLC · Class I

Cleared under the same submission

K103510 also covers:

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

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Manufacturer

Manufacturer: Tech Medical Services, Inc.

Sources (1)

FDA UDI e73ff07e-c327-464c-a6b7-6c524ef557f0 34 fields · synced Jun 1, 2026