FDA.reportPublic FDA data

BioGlue Surgical Adhesive

Primary DI
10877234000260
Brand
BioGlue Surgical Adhesive
Company
Cryolife, Inc.
Model
BGDTE-10
Catalog number
BGDTE-10
Device description
BioGlue Surgical Adhesive Delivery Tip Extension
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUQGlue,Surgical,Arteries

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUQGlue, Surgical, ArteriesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010003016

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010003016BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10877234000260PackageGS110In Commercial Distribution
00877234000263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087723400026010877234000260
00877234000263008772340002638772340002630877234000263

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery adhesive/sealant applicator, dual-channelA sterile dual-channel delivery device designed to enable a surgeon to apply with precision a two-component medication or adhesive/sealant to a surgical site during open surgery (e.g., arterial anastomosis, colonic anastomosis, and vascular graft reconstruction). The device, also known as a surgical sealant dispenser (SSD), is typically made of flexible metal or synthetic material, and has a connector at one end to attach a compatible dispensing device (e.g., a dual-component syringe). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-419-3355usbioglue@cryolife.com

Regulatory Flags#

DUNS number
119253177
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10877234000154BioGlue Surgical AdhesiveBGAT-SYBGAT-SY2016-12-12
10877234000178BioGlue Surgical AdhesiveBGAT-27-SYBGAT-27-SY2016-12-12
10877234000192BioGlue Surgical AdhesiveBGST-16BGST-162016-12-12
10877234000253BioGlue Surgical AdhesiveBG3510-5-USBG3510-5-US2016-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10877234001298BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
10877234001304BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
00877234000898BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
00877234000904BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
00877234000911BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
00877234000928BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
00877234000935BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
00877234000942BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
00877234001185BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
10877234000895BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
10877234000901BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
10877234000918BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
10877234000925BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
10877234000932BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
10877234000949BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
10877234001182BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
20877234001295BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
20877234001301BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
10877234001311BioGlue Surgical AdhesiveArtivion, Inc.MUQ2024-03-13
00877234000157BioGlue Surgical AdhesiveArtivion, Inc.MUQ2016-12-12
00877234000171BioGlue Surgical AdhesiveArtivion, Inc.MUQ2016-12-12
00877234000195BioGlue Surgical AdhesiveArtivion, Inc.MUQ2016-12-12
00877234000256BioGlue Surgical AdhesiveArtivion, Inc.MUQ2016-12-12
10877234000154BioGlue Surgical AdhesiveCryolife, Inc.MUQ2016-12-12
00877234000164BioGlue Surgical AdhesiveArtivion, Inc.MUQ2016-12-12
10877234000178BioGlue Surgical AdhesiveCryolife, Inc.MUQ2016-12-12
00877234000188BioGlue Surgical AdhesiveArtivion, Inc.MUQ2016-12-12
10877234000192BioGlue Surgical AdhesiveCryolife, Inc.MUQ2016-12-12
00877234000232BioGlue Surgical AdhesiveArtivion, Inc.MUQ2016-12-12
00877234000249BioGlue Surgical AdhesiveArtivion, Inc.MUQ2016-12-12