Ossigen 660-00-10

GUDID 10885862095022

Exactech, Inc.

Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 10885862095022
• NIH Device Record Key: 0db5aca4-5cd8-4ef7-80ee-21364011a448
• Commercial Distribution Discontinuation: 2024-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ossigen
• Version Model Number: 660-00-10
• Catalog Number: 660-00-10
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862095022 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-09-04
• Device Publish Date: 2016-07-17

Devices Manufactured by Exactech, Inc.

• 10885862656582 - Equinoxe: 2026-02-17
• 10885862657046 - CSB: 2026-02-05 CSB Cage Drill Pilot Tip, 0°
• 10885862657053 - CSB: 2026-02-05 CSB Cage Drill Pilot Tip 8°, 10°, 8°/10°
• 10885862657060 - CSB: 2026-02-05 CSB Non-Tapered Hex Driver
• 10885862657237 - CSB: 2026-02-05 CSB Drill Bushing
• 10885862658159 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +0, 12/14
• 10885862658166 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +3, 12/14
• 10885862658173 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +7, 12/14