Cerament™|bead Tray

FDA UDI

Class I (US FDA UDI)

by Bonesupport AB

Identity

Trade Name: CERAMENT™|BEAD TRAY FDA UDI
Generic Name: Synthetic bone graft bead mould FDA UDI
Device Name: A single use bead mold for molding beads out of ceramic bone graft substitutes. The bead mold consists of cavities in three different sizes. The cavities are filled with ceramic bone graft substitute and evenly distributed across the mold using the spatula. The ceramic bone graft substitute sets in the cavities and the ceramic bone graft substitute beads are then removed from the mold. FDA UDI
Model / Reference: A0513 FDA UDI
Description: A single use bead mold for molding beads out of ceramic bone graft substitutes. The bead mold consists of cavities in three different sizes. The cavities are filled with ceramic bone graft substitute and evenly distributed across the mold using the spatula. The ceramic bone graft substitute sets in the cavities and the ceramic bone graft substitute beads are then removed from the mold. FDA UDI

Identifiers

Primary DI / UDI-DI: 07350055430318 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Synthetic bone graft bead mould FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Synthetic bone graft bead mould

Cerament™|bead Tray by Bonesupport AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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: Bonesupport AB

Sources (1)

FDA UDI 1b631ba6-700d-4609-8c42-bac4365a6661 33 fields · synced May 30, 2026