Flo-Rester® Disposable Internal Vessel Occluder

Primary DI
50085412532016
Brand
Flo-Rester® Disposable Internal Vessel Occluder
Company
SYNOVIS LIFE TECHNOLOGIES, INC.
Model
50450
Catalog number
50450BIOS
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
OTC
false
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
50085412532016PackageGS15In Commercial Distribution
00085412532011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541253201650085412532016
00085412532011000854125320110854125320110085412532011

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular anastomosis occluderA sterile 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
017415781
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
false
Sterilization required before use
false

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

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