TissueGUARD

FDA UDI

Class I (US FDA UDI)

by TissueGUARD GmbH

Identity

Trade Name: TissueGUARD FDA UDI
Generic Name: Surgical instrument guard, single-use FDA UDI
Device Name: Tip Closure Cap for DMEK Injector. Single-use, disposable accessory to TissueGUARD DMEK Injector cannula. The intended use is to prevent the liquid flow from the cannula. There is no direct contact with the tissue. The device does not have any clinical indication. FDA UDI
Model / Reference: Tip Closure Cap for DMEK Injector FDA UDI
Description: Tip Closure Cap for DMEK Injector. Single-use, disposable accessory to TissueGUARD DMEK Injector cannula. The intended use is to prevent the liquid flow from the cannula. There is no direct contact with the tissue. The device does not have any clinical indication. FDA UDI

Identifiers

Catalog Number: TG-C003 FDA UDI
Primary DI / UDI-DI: 04262488440020 FDA UDI
FDA Product Code: LXZ FDA UDI
GMDN Term: Surgical instrument guard, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument guard, single-use

TissueGUARD by TissueGUARD GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument guard, single-use.

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ARROW — TELEFLEX INCORPORATED · Class II
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Oxboro ™ Osteotome Tip Protectors — Aspen Surgical Products, Inc. · Class I
Simpulse — Davol Inc. · Class II
Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
Steri-Pocket — Hanes Companies, Inc. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: TissueGUARD GmbH

Sources (1)

FDA UDI 94943ee8-5307-4043-817f-ebfb7d17911e 35 fields · synced May 30, 2026