BioGlue Surgical Adhesive BGST-16

GUDID 10877234000192

BioGlue Surgical Adhesive Syringe Spreader Tips

Cryolife, Inc.

Open-surgery adhesive/sealant applicator, dual-channel

• Primary Device ID: 10877234000192
• NIH Device Record Key: a432964a-3d24-4eed-be85-a6bd4d348793
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioGlue Surgical Adhesive
• Version Model Number: BGST-16
• Catalog Number: BGST-16
• 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: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877234000195 [Primary]
GS1	10877234000192 [Package]; Contains: 00877234000195; Package: Box [10 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: 4
• 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