BioGlue Surgical Adhesive

Primary DI
10877234001298
Brand
BioGlue Surgical Adhesive
Company
Artivion, Inc.
Model
BG3510-5-US
Catalog number
BG3510-5-US
Device description
10mL Syringe with Standard Applicator Tips
Published
2024-03-13
Public version status
New
Distribution status
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
P010003001
P010003002
P010003003
P010003004
P010003007
P010003008
P010003009
P010003012
P010003013
P010003014
P010003015
P010003020
P010003021
P010003022
P010003023
P010003024
P010003025
P010003027
P010003029
P010003030
P010003032
P010003036
P010003037
P010003038
P010003040
P010003041

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010003001BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003002BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003003BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003004BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003007BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003008BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003009BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003012BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003013BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003014BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003015BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003020BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003021BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003022BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003023BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003024BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003025BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003027BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003029BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003030BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003032BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003036BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003037BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003038BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003040BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003041BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20877234001295PackageGS15In Commercial Distribution
10877234001298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2087723400129520877234001295
1087723400129810877234001298

GMDN Terms#

Term, Definition table
TermDefinition
Surgical internal adhesive/sealant, animal-derivedA bioabsorbable substance containing animal-derived material [e.g., bovine serum albumin (BSA)/cross-linking agent] intended to be used for internal surgical applications to bond or seal cut, incised, or resected body tissues (e.g., for vascular anastomosis) typically as an adjunct to standard methods of closure, to seal leaks, and might in addition be intended to achieve haemostasis through tissue sealing. Disposable mixing devices/applicators may be included for preparation and application to anatomical sites. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
7704193355customerservice.us@artivion.com

Regulatory Flags#

DUNS number
119253177
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
10877234001304BioGlue Surgical AdhesiveBG3515-5-USBG3515-5-US2024-03-13
00877234000898BioGlue Surgical AdhesiveBGAT-27-SYBGAT-27-SY2024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10877234000253BioGlue Surgical AdhesiveCryolife, Inc.MUQ2016-12-12