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
00643169694859TrailBlazer™AngledASC-014-0902016-10-22
00643169694866TrailBlazer™AngledASC-014-1352016-10-22
00643169694873TrailBlazer™AngledASC-014-1502016-10-22
00643169694880TrailBlazer™AngledASC-018-0902016-10-22
00643169694897TrailBlazer™AngledASC-018-1352016-10-22
00643169694903TrailBlazer™AngledASC-018-1502016-10-22
00643169694910TrailBlazer™AngledASC-035-0652016-10-22
00643169694927TrailBlazer™AngledASC-035-0902016-10-22
00643169694934TrailBlazer™AngledASC-035-1352016-10-22
00643169694941TrailBlazer™AngledASC-035-1502016-10-22
00763000004804TrailBlazer™ AngledASC-014-0902017-12-22
00763000004811TrailBlazer™ AngledASC-014-1352017-12-22
00763000004828TrailBlazer™ AngledASC-014-1502017-12-22
00763000004835TrailBlazer™ AngledASC-018-0902017-12-22
00763000004842TrailBlazer™ AngledASC-018-1352017-12-22
00763000004859TrailBlazer™ AngledASC-018-1502017-12-22
00763000004866TrailBlazer™ AngledASC-035-0652017-12-22
00763000004873TrailBlazer™ AngledASC-035-0902017-12-22
00763000004880TrailBlazer™ AngledASC-035-1352017-12-22
00763000004897TrailBlazer™ AngledASC-035-1502017-12-22

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Primary DI, Brand, Company table
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