FDA.reportPublic FDA data

Prelude® Short Sheath

Primary DI
20884450015326
Brand
Prelude® Short Sheath
Company
Merit Medical Systems, Inc.
Model
10884450015329
Catalog number
PSS-7F-4MT
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082063000PRELUDE SHORT SHEATH INTRODUCERMerit Medical Systems, Inc.2008-10-15DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450015326PackageGS14In Commercial Distribution
10884450015329PrimaryGS10
00884450015322Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445001532620884450015326
1088445001532910884450015329
00884450015322008844500153228844500153220884450015322

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00884450099346Merit Medical®Initial ReleaseK05-02879B2026-11-05
00884450163351Merit Medical®Initial ReleaseK09-11704C2026-11-05
00884450420034Merit Medical®Initial ReleaseK09-14260A2026-11-05
00884450420263Merit Medical®Initial ReleaseK09-11289A2026-11-05
00884450431535Merit Medical®Initial ReleaseK12-04729B2026-11-05
00884450436530Merit Medical®Initial ReleaseK09-05978D2026-11-05
00884450436974Merit Medical®Initial ReleaseK09-09344D2026-11-05
00884450508763Merit Medical®Initial ReleaseK09-13864D2026-11-05
00884450163917Merit Medical®Initial ReleaseK09-12030B2026-11-04
00884450431443Merit Medical®Initial ReleaseK08-03296A2026-11-04
00884450456385ReSolve®GRBDC-14-0382026-11-04
00884450503829Merit Medical®Initial ReleaseK09-13310D2026-11-04
00884450794739DuraMax®AH7871030290152026-11-03
00884450838228Prelude Roadster™APG8F45S2026-11-03
00884450839355Prelude Roadster™APG7F90SX2026-11-04
10884450708467Prelude®FPSI-7F-11-038-18G2026-11-03
00884450148174Merit Medical®Initial ReleaseK09-09012A2026-10-31
00884450428061Merit Medical®Initial ReleaseK10-01518B2026-10-31
00884450436936Merit Medical®Initial ReleaseK12-07972A2026-10-30
00884450499191Merit MAK™GMAK401N-E2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450839355Prelude Roadster™Merit Medical Systems, Inc.DYB2026-11-04
06954615625766Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626572Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626589Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626596Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626602Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
00884450838228Prelude Roadster™Merit Medical Systems, Inc.DYB2026-11-03
00884450839362Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-30
00884450838129Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-29
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00389701009261PINNACLETERUMO MEDICAL CORPORATIONDYB2018-03-21
00382903840120BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840083BD Introsyte-N Autoguard, BD InstaflashBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840106BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840113BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00389701006161DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006178DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006185DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006192DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006208DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006215DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006222DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006239DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006246DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006253DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006260DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006277DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006796DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006802DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006970DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24