SRH3427LBlue Sky Bio, LLC

GUDID 00810060223123

Bone Condenser 8/9

BLUE SKY BIO LLC

Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block Bone graft packing block

• Primary Device ID: 00810060223123
• NIH Device Record Key: df35b1c3-d578-49eb-b173-59e6c742c2e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SRH3427LBlue Sky Bio, LLC
• Version Model Number: STPCND89
• 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	00810060223123 [Primary]

FDA Product Code

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

Sterilization

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

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

[00810060223123]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-10-21
• 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