Blue Sky Bio, LLC.

GUDID 00810060225035

BIO | Zygomatic Diamond Burr

BLUE SKY BIO LLC

Fixture/appliance dental drill bit, reusable

• Primary Device ID: 00810060225035
• NIH Device Record Key: bb544ebb-fb5a-42cc-93ce-b55b9de6a907
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blue Sky Bio, LLC.
• Version Model Number: BURZD
• 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	00810060225035 [Primary]

FDA Product Code

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

Sterilization

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

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

[00810060225035]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-26
• Device Publish Date: 2022-10-18

On-Brand Devices [Blue Sky Bio, LLC.]

• 00815131027525: Z9822C1
• 00815131027518: Z9818C1
• 00815131027501: Z4019D4
• 00815131027495: Z9822D4
• 00815131027488: Z9818D4
• 00815131027471: Z9816D4
• 00815131027464: Z9814D4
• 00815131027457: Z4019D3
• 00815131027440: Z9822D3
• 00815131027433: Z9818D3
• 00815131027426: Z9816D3
• 00815131027419: Z9814D3
• 00815131027402: Z4019D2
• 00815131027396: Z9822D2
• 00815131027389: Z9818D2
• 00815131027372: Z9816D2
• 00815131027365: Z9814D2
• 00815131027358: Z4019C4
• 00815131027341: Z9822C4
• 00815131027334: Z9818C4
• 00815131027327: Z9816C4
• 00815131027310: Z9814C4
• 00815131027303: Z4019C3
• 00815131027297: Z9822C3
• 00815131027280: Z9818C3
• 00815131027273: Z9816C3
• 00815131027266: Z9814C3
• 00815131027259: Z4019C2
• 00815131027242: Z9822C2
• 00815131027235: Z9818C2
• 00815131027228: Z9816C2
• 00815131027211: Z9814C2
• 00815131027204: Z4019C1
• 00815131027198: Z9816C1
• 00815131027181: Z9814C1
• 00815131027174: Z4019B4
• 00815131027167: Z9822B4
• 00815131027150: Z9818B4
• 00815131027143: Z9816B4
• 00815131027136: Z9814B4
• 00815131027129: Z4019B3
• 00815131027112: Z4019B2
• 00815131027105: Z9822B3
• 00815131027099: Z9818B3
• 00815131027082: Z9816B3
• 00815131027075: Z9814B3
• 00815131027068: Z9818B2
• 00815131027051: Z9822B2
• 00815131027044: Z9816B2
• 00815131027037: Z9814B2