FDA.reportPublic FDA data

ReSolve ConvertX®

Primary DI
20884450458642
Brand
ReSolve ConvertX®
Company
Merit Medical Systems, Inc.
Model
00884450458648
Catalog number
RCXB7-10-038/A
Published
2021-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGEStents, drains and dilators for the biliary ducts

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181669000ConvertX Biliary Stent SystemBrightwater Medical2019-03-14FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450458645PackageGS11In Commercial Distribution
20884450458642PackageGS15In Commercial Distribution
00884450458648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445045864510884450458645
2088445045864220884450458642
00884450458648008844504586488844504586480884450458648

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric biliary stent, non-bioabsorbableA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
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
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
00884450431252Merit Medical®Initial ReleaseK09-11873C2026-09-04
00884450431979Merit Medical®Initial ReleaseK09-14157A2026-09-04
00884450456217Merit Medical®ALR-SGH0012026-09-04
00884450456224Merit Medical®ALR-CEX0012026-09-04
00884450456231Merit Medical®ALR-PVP0012026-09-04
00884450501696Merit Medical®Initial ReleaseK12T-12741A2026-09-04
10884450457549C2 CryoBalloon™AFG-10502026-09-05
00884450430118Merit Medical®Initial ReleaseK12-05157A2026-08-27
00884450440544Merit ®ALR-STS0012026-08-27
00884450450970Merit Medical®ALR-CLP0022026-08-27
00884450466995Needle's Eye Snare®ALR-NES0022026-08-27
00884450685785SCOUT®TSSR05-012026-08-27
00884450685792SCOUT®TSSR10-012026-08-27
00884450685808SCOUT®TSSR75-012026-08-27
00884450685822SCOUT MD™BSGMD-012026-07-01
00884450685839SCOUT MD™BSGMD-022026-07-01
00884450840597Prelude Roadster™APG4F90S2026-08-27
10884450119836Prelude EASE™JPHR6F11025PW2026-08-27
00884450435748SCOUT®MSG-012026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15711055003237M-DrainMermaid Medical A/SFGE2026-09-04
15711055003244M-DrainMermaid Medical A/SFGE2026-09-04
04052838002417Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002431Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002448Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002455Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002462Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002479Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002486Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002493Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002509Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002516Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002523Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002530Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002547Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002554Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002561Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002578Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002585Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002592Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002608Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002615Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002622Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002639Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002646Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002653Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002660Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002677Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002684Endoflux™Medi-Globe GmbHFGE2026-08-27