OsteoRepair-Inject DB-O-I20CC

GUDID 00850018568074

BONE VOID FILLER

DIMENSIONAL BIOCERAMICS LLC

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00850018568074
• NIH Device Record Key: 0ee45ca9-37ca-46d3-ae5d-6bc928efb7c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoRepair-Inject
• Version Model Number: DB-O-I20CC
• Catalog Number: DB-O-I20CC
• Company DUNS: 080276169
• Company Name: DIMENSIONAL BIOCERAMICS LLC
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018568074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200752

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-13
• Device Publish Date: 2021-07-05

On-Brand Devices [OsteoRepair-Inject]

• 00850018568074: BONE VOID FILLER
• 00850018568067: BONE VOID FILLER
• 00850018568050: BONE VOID FILLER
• 00850018568043: BONE VOID FILLER