FDA.reportPublic FDA data

Paramount Mini GPS

Primary DI
00821684006641
Brand
Paramount Mini GPS
Company
Covidien LP
Model
PMB8-7-21-80
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
00821684006641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821684006641008216840066418216840066410821684006641

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 Gauge6French
Device Size Text, specify0
Length21Millimeter
Outer Diameter7Millimeter

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
10884521072602V-LocVLOCN204L2015-09-02
20884521126852Sofsilk1700022016-09-24
10884521091986NellcorSC-A-I2026-05-25
10884521758803Vascufil8886470311V-22020-07-19
10884521816312McGRATH MAC350-005-0002021-10-21
10884521816329McGRATH MAC350-013-0002021-08-30
10884521816336McGRATH MAC350-017-0002021-10-18
10884521816343McGRATH MAC350-072-0002022-06-13
10884521824317McGRATH MAC350-005-0002022-09-25
10884521824324McGRATH MAC350-013-0002021-10-30
10884521824331McGRATH MAC350-017-0002021-08-26
10884521824348McGRATH MAC350-072-0002023-06-19
10884521850118McGRATH MAC350-005-0002025-04-27
10884521850125McGRATH MAC350-013-0002025-04-27
10884521850132McGRATH MAC350-017-0002025-04-27
10884521850149McGRATH MAC350-072-0002025-04-27
15060272980310McGRATH MAC350-005-0002021-08-02
15060272980327McGRATH MAC350-013-0002022-01-17
15060272980334McGRATH MAC350-072-0002021-04-18
15060272980341McGRATH MAC350-017-0002021-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729793328MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793335MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793342MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793359MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793366MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793373MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793380MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793397MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793403MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793410MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793427MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793434MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793441MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793458MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793465MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793472MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793489MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793496MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793502MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793519MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793526MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793533MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729029618vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729030638Amplatz Anchor™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729030645Amplatz Anchor™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729030652Amplatz Anchor™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729079552Flexima™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729113829vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729113836vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729113843vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24