SRH3427LBlue Sky Bio, LLC

GUDID 00810060223086

Bone Condenser 2/3

BLUE SKY BIO LLC

Bone graft packing block

• Primary Device ID: 00810060223086
• NIH Device Record Key: 6556645b-0818-48d0-be09-ba5abbceb9a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SRH3427LBlue Sky Bio, LLC
• Version Model Number: STPCND23
• Company DUNS: 618960848
• Company Name: BLUE SKY BIO LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00810060223086 [Primary]

FDA Product Code

• EBL: Pin, Retentive And Splinting, And Accessory Instruments

Sterilization

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

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

[00810060223086]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-29
• Device Publish Date: 2021-07-21

On-Brand Devices [SRH3427LBlue Sky Bio, LLC]

• 00810060223093: Bone Condenser 4/5
• 00810060223086: Bone Condenser 2/3
• 00810060223079: Bone Condenser 10/11
• 00810060223062: BIO | Quattro Screw Impression Transfer
• 00810060223055: BIO | Quattro Screw Impression Open Tray
• 00810060223048: Screw Internal Hex Impression Coping Long
• 00810060223123: Bone Condenser 8/9
• 00810060223109: Bone Condenser 6/7