FDA.reportPublic FDA data

Flo-Rester® Disposable Internal Vessel Occluder

Primary DI
00085412532110
Brand
Flo-Rester® Disposable Internal Vessel Occluder
Company
SYNOVIS LIFE TECHNOLOGIES, INC.
Model
60275
Catalog number
60275
Device description
Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs on the distal ends of a flexible shaft. A tab on a tether is attached to the midpoint of the flexible shaft forming a T configuration. Flo-Rester bulbs and tab are radiopaque.
Published
2016-09-24
Public version status
Update
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
DXCCLAMP, VASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K883696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K883696000FLO-RESTERBio-Vascular, Inc.1988-11-30DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412532115PackageGS15In Commercial Distribution
00085412532110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541253211550085412532115
00085412532110000854125321100854125321100085412532110

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular anastomosis occluderA device designed to temporarily occlude the flow of blood in the lumen of a blood vessel at a vascular anastomosis, primarily to control bleeding and enable operative field visualization during coronary or peripheral vascular bypass grafting and vessel repair surgery. It is typically designed as a flexible shaft with dilated/bulbous ends that is entirely inserted into the vessel lumen via a small incision at the surgical site to arrest blood flow at the anastomosis; it will typically have an external tab or tether used for its removal. It is typically made of silicone elastomer and polyester radiopaque materials and is available in a range of diameters. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
017415781
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412531212VERITAS COLLAGEN MATRIXRM-0818RM0818BIO2015-10-05
00085412531076VERITAS COLLAGEN MATRIXRM-0208RM0208BIO2015-10-05
00085412531090VERITAS COLLAGEN MATRIXRM-0304RM0304BIO2015-10-05
00085412531113VERITAS COLLAGEN MATRIXRM-0407RM0407BIO2015-10-05
00085412531137VERITAS COLLAGEN MATRIXRM-0416RM0416BIO2015-10-05
00085412531151VERITAS COLLAGEN MATRIXRM-0608RM0608BIO2015-10-05
00085412531175VERITAS COLLAGEN MATRIXRM-0618RM0618BIO2015-10-05
00085412531199VERITAS COLLAGEN MATRIXRM-0816RM0816BIO2015-10-05
00085412531236VERITAS COLLAGEN MATRIXRM-1016RM1016BIO2015-10-05
00085412531250VERITAS COLLAGEN MATRIXRM-1212RM1212BIO2015-10-05
00085412531274VERITAS COLLAGEN MATRIXRM-1225RM1225BIO2015-10-05
00085412658681Peri-Strips Dry with VeritasPSDA45GIAPSDA45GIA2024-11-21
00085412658834Peri-Strips Dry with VeritasPSDA45GIATHNPSDA45GIATHN2024-11-21
50085412658686Peri-Strips Dry with VeritasPSDA45GIAPSDA45GIA2024-11-21
50085412658839Peri-Strips Dry with VeritasPSDA45GIATHNPSDA45GIATHN2024-11-21
00085412818405Peri-GuardPG0404PG04042023-05-15
00085412530529Peri-GuardPC0404NPC0404NBIO2015-10-08
00085412530567Peri-GuardPC0608NPC0608NBIO2015-10-08
00085412530581Peri-GuardPC0814NPC0814NBIO2015-10-08
00085412530604Peri-GuardPC1016NPC1016NBIO2015-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896124011Debakey Beck ClampSONTEC INSTRUMENTS, INC.DXC2026-10-27
00192896124028Debakey Beck ClampSONTEC INSTRUMENTS, INC.DXC2026-10-27
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00190776436643MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776436681MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776437763MillenniumAvalign Technologies, Inc.DXC2026-10-20
00190776435226MillenniumAvalign Technologies, Inc.DXC2026-10-19
00190776436230MillenniumAvalign Technologies, Inc.DXC2026-10-08
00190776436247MillenniumAvalign Technologies, Inc.DXC2026-10-08
M68931200070CrOCSafeguard US Operating, LLCDXC2026-10-08
00190776434267MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434335MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434366MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434373MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776433314MillenniumAvalign Technologies, Inc.DXC2026-10-05
00810220800577Adler Instrument CompanyAdler, Inc.DXC2026-09-30
00846159036411SCANLAN® ClampSCANLAN INTERNATIONAL INCDXC2026-09-21
00846159036428SCANLAN® ClampSCANLAN INTERNATIONAL INCDXC2026-09-21
00190776424107MillenniumAvalign Technologies, Inc.DXC2026-08-27
00190776423889MillenniumAvalign Technologies, Inc.DXC2026-08-26
00190776420345MillenniumAvalign Technologies, Inc.DXC2026-08-25
00190776419080MillenniumAvalign Technologies, Inc.DXC2026-08-23
00190776419127MillenniumAvalign Technologies, Inc.DXC2026-08-23
00190776417154MillenniumAvalign Technologies, Inc.DXC2026-08-19
00190776411527MillenniumAvalign Technologies, Inc.DXC2026-08-07
00190776408633MillenniumAvalign Technologies, Inc.DXC2026-08-03
00190776422318MillenniumAvalign Technologies, Inc.DXC2026-07-31
00885403523000FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523161FOGARTY HYDRAJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523253FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30