Cytoplast™ Osteo-Mesh TM-300

FDA UDI

Class II (US FDA UDI)

by Osteogenics Biomedical, Inc.

Identity

Trade Name: Cytoplast™ Osteo-Mesh TM-300 FDA UDI
Generic Name: Extra-gynaecological surgical mesh, metal FDA UDI
Device Name: Titanium Ridge Augmentation Mesh, 25 mm x 34 mm, Non-sterile FDA UDI
Model / Reference: TM2534NS FDA UDI
Description: Titanium Ridge Augmentation Mesh, 25 mm x 34 mm, Non-sterile FDA UDI

Identifiers

Primary DI / UDI-DI: D765TM2534NS0 FDA UDI
FDA Product Code: JEY FDA UDI
GMDN Term: Extra-gynaecological surgical mesh, metal FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4760 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 34 Millimeter FDA UDI
Width — 25 Millimeter FDA UDI

Category: Extra-gynaecological surgical mesh, metal

Cytoplast™ Osteo-Mesh TM-300 by Osteogenics Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Extra-gynaecological surgical mesh, metal.

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Pyramesh® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
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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: Osteogenics Biomedical, Inc.

Sources (1)

FDA UDI c0f98563-635b-463f-a475-bd1a35efa945 34 fields · synced Jun 6, 2026