BioGlue Surgical Adhesive BG3515-5-US

GUDID 20877234001301

5mL Syringe and Standard Applicator Tips

Artivion, Inc.

Surgical internal adhesive/sealant, animal-derived
Primary Device ID20877234001301
NIH Device Record Keybc5f1716-f60a-44ba-a425-6848b577fb3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioGlue Surgical Adhesive
Version Model NumberBG3515-5-US
Catalog NumberBG3515-5-US
Company DUNS119253177
Company NameArtivion, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7704193355
Emailcustomerservice.us@artivion.com
Phone7704193355
Emailcustomerservice.us@artivion.com
Phone7704193355
Emailcustomerservice.us@artivion.com
Phone7704193355
Emailcustomerservice.us@artivion.com
Phone7704193355
Emailcustomerservice.us@artivion.com
Phone7704193355
Emailcustomerservice.us@artivion.com
Phone7704193355
Emailcustomerservice.us@artivion.com
Phone7704193355
Emailcustomerservice.us@artivion.com
Phone7704193355
Emailcustomerservice.us@artivion.com
Phone7704193355
Emailcustomerservice.us@artivion.com
Phone7704193355
Emailcustomerservice.us@artivion.com
Phone7704193355
Emailcustomerservice.us@artivion.com
Phone7704193355
Emailcustomerservice.us@artivion.com

Device Dimensions

Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110877234001304 [Primary]
GS120877234001301 [Package]
Contains: 10877234001304
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUQGlue, Surgical, Arteries

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-21
Device Publish Date2024-03-13

On-Brand Devices [BioGlue Surgical Adhesive]

108772340013112mL Syringe and Standard Applicator Tips
208772340013015mL Syringe and Standard Applicator Tips
2087723400129510mL Syringe with Standard Applicator Tips
10877234001182BioGlue Surgical Adhesive Applicator Tips
10877234000949BioGlue Surgical Adhesive Delivery Tip Extension
10877234000932BioGlue Surgical Adhesive Delivery Tip Extension
10877234000925BioGlue Surgical Adhesive Syringe Spreader Tips
10877234000918BioGlue Surgical Adhesive Syringe Spreader Tips
10877234000901BioGlue Surgical Adhesive Syringe Extender Tips
10877234000895BioGlue Surgical Adhesive Syringe Extender Tips

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