BioGlue Surgical Adhesive BG3515-5-US

GUDID 00877234000249

5mL Syringe and Standard Applicator Tips

Cryolife, Inc.

Surgical adhesive/sealant, animal-derived

• Primary Device ID: 00877234000249
• NIH Device Record Key: b6aa84bb-f377-422a-9d74-58408e756c82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioGlue Surgical Adhesive
• Version Model Number: BG3515-5-US
• Catalog Number: BG3515-5-US
• Company DUNS: 119253177
• Company Name: Cryolife, Inc.
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com
• Phone: 770-419-3355
• Email: usbioglue@cryolife.com

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877234000249 [Primary]
GS1	10877234000246 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010003

FDA Product Code

• MUQ: Glue,Surgical,Arteries

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-12

On-Brand Devices [BioGlue Surgical Adhesive]

• 00877234000270: BioGlue Surgical Adhesive Delivery Tip Extension
• 10877234000260: BioGlue Surgical Adhesive Delivery Tip Extension
• 10877234000253: 10 mL Syringe, Standard Applicator Tips, and Syringe Spreader Tips
• 00877234000249: 5mL Syringe and Standard Applicator Tips
• 00877234000232: 2mL Syringe and Standard Applicator Tips
• 10877234000192: BioGlue Surgical Adhesive Syringe Spreader Tips
• 00877234000188: BioGlue Surgical Adhesive Syringe Spreader Tips
• 10877234000178: BioGlue Surgical Adhesive Syringe Extender Tips
• 00877234000164: BioGlue Surgical Adhesive Syringe Extender Tips
• 10877234000154: BioGlue Surgical Adhesive Applicator Tips