Bioglue Surgical Adhesive BGDTE-27

GUDID 00877234000270

BioGlue Surgical Adhesive Delivery Tip Extension

Cryolife, Inc.

Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel
Primary Device ID00877234000270
NIH Device Record Key05746f8a-8d59-4cb1-986e-e126ef657e93
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioglue Surgical Adhesive
Version Model NumberBGDTE-27
Catalog NumberBGDTE-27
Company DUNS119253177
Company NameCryolife, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com
Phone770-419-3355
Emailusbioglue@cryolife.com

Device Dimensions

Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100877234000270 [Primary]
GS110877234000277 [Package]
Package: Box [10 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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-02-04

On-Brand Devices [Bioglue Surgical Adhesive]

00877234000270BioGlue Surgical Adhesive Delivery Tip Extension
10877234000260BioGlue Surgical Adhesive Delivery Tip Extension
1087723400025310 mL Syringe, Standard Applicator Tips, and Syringe Spreader Tips
008772340002495mL Syringe and Standard Applicator Tips
008772340002322mL Syringe and Standard Applicator Tips
10877234000192BioGlue Surgical Adhesive Syringe Spreader Tips
00877234000188BioGlue Surgical Adhesive Syringe Spreader Tips
10877234000178BioGlue Surgical Adhesive Syringe Extender Tips
00877234000164BioGlue Surgical Adhesive Syringe Extender Tips
10877234000154BioGlue Surgical Adhesive Applicator Tips
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