BioGlue Surgical Adhesive

Primary DI
00877234000164
Brand
BioGlue Surgical Adhesive
Company
Artivion, Inc.
Model
BGAT-10-SY
Catalog number
BGAT-10-SY
Device description
BioGlue Surgical Adhesive Syringe Extender Tips
Published
2016-12-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
P010003006
P010003022
P010003027
P010003028

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010003006BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003022BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003027BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003028BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10877234000161PackageGS110In Commercial Distribution
00877234000164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087723400016110877234000161
00877234000164008772340001648772340001640877234000164

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 Temperature0 Degrees Celsius25 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
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00877234001635PhotoFix Decellularized Bovine PericardiumPFP6X8PFP6X82026-05-29
00877234001642PhotoFix Decellularized Bovine PericardiumPFP0.8X8PFP0.8X82026-05-29
00877234001659PhotoFix Decellularized Bovine PericardiumPFP1X6PFP1X62026-05-29
00877234001666PhotoFix Decellularized Bovine PericardiumPFP4X4PFP4X42026-05-29
00877234001673PhotoFix Decellularized Bovine PericardiumPFP2X9PFP2X92026-05-29
00877234001680PhotoFix Decellularized Bovine PericardiumPFP1X10PFP1X102026-05-29
00877234001697PhotoFix Decellularized Bovine PericardiumPFP1X14PFP1X142026-05-29
00877234001703PhotoFix Decellularized Bovine PericardiumPFP8X14PFP8X142026-05-29
00877234000096CardioGenesisNS2000LSR-SG2100S2016-12-12
00877234000447CryoValve® SG Pulmonary Human Heart Valve SGPV00SGPV002015-09-11
00877234000454CryoValve® SG Pulmonary Human Heart Valve SGPV10SGPV102015-09-11
00877234000102CardioGenesisHP-SG3HP-SG32016-12-12
00877234001192"AMDS Hybrid Prosthesis (""AMDS"")"K039420AMDS40 2025-02-05
00877234001208"AMDS Hybrid Prosthesis (""AMDS"")"K039421AMDS4030 2025-02-05
00877234001215"AMDS Hybrid Prosthesis (""AMDS"")"K039422AMDS55 2025-02-05
00877234001222"AMDS Hybrid Prosthesis (""AMDS"")"K039423AMDS55402025-02-05
00877234001321"AMDS Hybrid Prosthesis (""AMDS"")"K038896AMDS4030c 2025-02-05
00877234001338"AMDS Hybrid Prosthesis (""AMDS"")"K038895AMDS40c 2025-02-05
10877234001298BioGlue Surgical AdhesiveBG3510-5-USBG3510-5-US2024-03-13
10877234001304BioGlue Surgical AdhesiveBG3515-5-USBG3515-5-US2024-03-13

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
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
10877234000253BioGlue Surgical AdhesiveCryolife, Inc.MUQ2016-12-12