FDA.reportPublic FDA data

NA

Primary DI
00858778006003
Brand
NA
Company
FOOTPRINT MEDICAL, INC.
Model
SHEATH1.4
Device description
1.4Fr Peel-Away Sheath Introducer
Published
2016-09-19
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093026000FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCERFootprint Medical2010-02-24DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858778006000PackageGS15In Commercial Distribution
00858778006003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085877800600010858778006000
00858778006003008587780060038587780060030858778006003

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
2102262600info@footprintmed.com

Regulatory Flags#

DUNS number
791238046
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
00858778006867N/AP1PIC1.4-STY2025-06-26
00858778006874N/AP1PIC1.9-STY2025-06-26
00858778006881N/AP2PIC1.9-STY2025-06-26
00858778006850N/APROBE-UMB2024-03-28
00858778006010NASHEATH1.92016-09-20
00859950007450NAP1FTS4.0-EN2022-09-29
00859950007467NAP1FTS5.0-EN2022-09-29
00859950007474NAP1FTS6.5-EN2022-09-29
00859950007481NAP1FTS8.0-EN2022-09-29
00859950007498NAP1FTM4.0-EN2022-09-29
00859950007504NAP1FTM5.0-EN2022-09-29
00859950007511NAP1FTM6.5-EN2022-09-29
00859950007528NAP1FTM8.0-EN2022-09-29
00859950007535NAP1FTL5.0-EN2022-09-29
00859950007542NAP1FTL6.5-EN2022-09-29
00859950007559NAP1FTL8.0-EN2022-09-29
00859950007566NAP1FTL10.0-EN2022-09-29
00859950007573NAS1FTS5.0-EN2022-09-29
00859950007580NAS1FTS6.5-EN2022-09-29
00859950007597NAS1FTS8.0-EN2022-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450438791Prelude® Short SheathMerit Medical Systems, Inc.DYB2026-10-06
10884450119751Prelude EASE™Merit Medical Systems, Inc.DYB2026-09-29
10884450439163Prelude IDeal™Merit Medical Systems, Inc.DYB2026-09-29
10884450439187Prelude IDeal™Merit Medical Systems, Inc.DYB2026-09-29
10801902226188ARROWTELEFLEX INCORPORATEDDYB2026-09-28
10801902228700ARROWTELEFLEX INCORPORATEDDYB2026-09-22
10884450489809Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489816Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489823Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489847Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489854Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489861Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489878Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489885Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489908Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489915Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489922Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489953Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489960Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489977Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489984Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510664Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03