Blue Sky Bio, LLC

Basic Information

• Brand Name: Blue Sky Bio, LLC
• Primary DI: 00810060223161
• Version / Model: TUBE22
• Company Name: BLUE SKY BIO LLC
• Labeler DUNS: 618960848
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-21
• Public Version: 2
• Public Version Date: 2022-10-20
• Public Version Status: Update
• Public Device Record Key: 6d5e0d75-1365-4d5c-a2f6-933b4a45b6b4

Device Description

BIO | Guide-Tube 2.2mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	872.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61946	Surgical torque wrench adaptor	A component of a surgical wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a variety of distal end pieces (bits). It is intended to be used during an invasive surgical procedure, and is not dedicated to dental use only. It may be referred to as a driver. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810060223161	GS1