CERAMENT™|BEAD TRAY

GUDID 07350055430318

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.

Bone Support AB

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• Primary Device ID: 07350055430318
• NIH Device Record Key: 1b631ba6-700d-4609-8c42-bac4365a6661
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERAMENT™|BEAD TRAY
• Version Model Number: A0513
• Company DUNS: 350066052
• Company Name: Bone Support AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350055430318 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-15
• Device Publish Date: 2023-06-07

Devices Manufactured by Bone Support AB

• 07350055430523 - CERAMENT® G: 2024-02-09 CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic ant
• 07350055430530 - CERAMENT® G: 2024-02-09 CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic ant
• 07350055430318 - CERAMENT™|BEAD TRAY: 2023-06-15A 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.
• 07350055430318 - CERAMENT™|BEAD TRAY: 2023-06-15 A single use bead mold for molding beads out of ceramic bone graft substitutes. The bead mold consists of cavities in three diff
• 07350055430394 - CERAMENT® G: 2022-12-14 CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic ant
• 07350055430387 - CERAMENT® G: 2022-10-13 CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic ant
• 07350055430035 - CERAMENT™BONE VOID FILLER: 2018-12-06
• 07350055430042 - CERAMENT™BONE VOID FILLER: 2018-12-06
• 07350055430066 - CERAMENT™BONE VOID FILLER: 2018-12-06