FDA.reportPublic FDA data

BioGlue Surgical Adhesive

Primary DI
00877234000188
Brand
BioGlue Surgical Adhesive
Company
Artivion, Inc.
Model
BGST-12
Catalog number
BGST-12
Device description
BioGlue Surgical Adhesive Syringe Spreader 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
P010003005
P010003006
P010003027

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010003005BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003006BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ
P010003027BIOGLUE SURGICAL ADHESIVECryolife, Inc.2001-12-03MUQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10877234000185PackageGS110In Commercial Distribution
00877234000188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087723400018510877234000185
00877234000188008772340001888772340001880877234000188

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
00877234001727Chord-X® Premeasured Loops, 24mm loop (3/8 circle)CXL-20-1838-24CXL-20-1838-242026-10-30
00877234001741Chord-X® Premeasured Loops, 20mm loop (3/8 circle)CXL-20-1838-20CXL-20-1838-202026-10-30
00877234001765Chord-X® Premeasured Loops, 16mm loop (3/8 circle)CXL-20-1838-16CXL-20-1838-162026-10-30
00877234001789Chord-X® Premeasured Loops, 12mm loop (3/8 circle)CXL-20-1838-12CXL-20-1838-122026-10-30
00877234001802Chord-X® Suture System, Adjustable (3/8 circle)CXL-20-1838-0CXL-20-1838-02026-10-30
00877234001826Chord-X® Premeasured Loops, 24mm loop (1/2 circle)CXL-20-1812-24CXL-20-1812-242026-10-30
00877234001840Chord-X® Premeasured Loops, 20mm loop (1/2 circle)CXL-20-1812-20CXL-20-1812-202026-10-30
00877234001864Chord-X® Premeasured Loops, 16mm loop (1/2 circle)CXL-20-1812-16CXL-20-1812-162026-10-30
00877234001888Chord-X® Premeasured Loops, 12mm loop (1/2 circle)CXL-20-1812-12CXL-20-1812-122026-10-30
00877234001901Chord-X® Suture System, Adjustable (1/2 circle)CXL-20-1812-0CXL-20-1812-02026-10-30
00877234001918Chord-X® Chordal SizerCXCSCXCS2026-10-30
00877234001420AMDS Hybrid Prosthesis ("AMDS")K060004AMDS40c2026-08-07
00877234001437AMDS Hybrid Prosthesis ("AMDS")K060005AMDS4030c2026-08-07
00877234001444AMDS Hybrid Prosthesis ("AMDS")K060006AMDS552026-08-07
00877234001451AMDS Hybrid Prosthesis ("AMDS")K060007AMDS55402026-08-07
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

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
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