FDA.reportPublic FDA data

Paramount Mini GPS

Primary DI
00821684006450
Brand
Paramount Mini GPS
Company
Covidien LP
Model
PMB4-6-21-80
Device description
Balloon-Expandable Biliary Stent System
Published
2015-10-16
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
FGECATHETER, BILIARY, DIAGNOSTIC

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040653000PARAMOUNT MINI GPS BILIARY STENT SYSTEMEv3, Inc.2004-04-28FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821684006450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821684006450008216840064508216840064500821684006450

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal biliary stentA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French
Device Size Text, specify0
Length21Millimeter
Outer Diameter6Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Keep Dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
968903703
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521701243INVOSPMAC71DOC2024-04-14
10884521810105INVOSPM71002021-06-14
10884521780170INVOSPMAC71DOC2019-07-31
10884521780071INVOSPM71002019-06-12
10884521839830TrexonCY904P2026-10-10
10884521839861TrexonCY954P2026-10-10
10884521840089TrexonCY811P2026-10-10
10884521840126TrexonCY843P2026-10-10
10884521840140TrexonCY883P2026-10-10
10884521840171TrexonCY953P2026-10-10
10884521840195TrexonGY123P2026-10-10
10884521840249TrexonGY323P2026-10-10
10884521840263TrexonSY823P2026-10-10
10884521840270TrexonSY923P2026-10-10
10884521840379TrexonGY122P2026-10-10
10884521840409TrexonGY322P2026-10-10
10884521840430TrexonSY5628P2026-10-10
10884521840447TrexonSY5638P2026-10-10
10884521840454TrexonSY5679GP2026-10-10
10884521840461TrexonSY632P2026-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078427250ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427267ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427274ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427281ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427298ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427304ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427311ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427328ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427335ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427342ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427359ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427366ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427373ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427380ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427397ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427403ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427410ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427427ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427434ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427441ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427458ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427465ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427472ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427489ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427496ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
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