FDA.reportPublic FDA data

Protégé EverFlex™

Primary DI
00821684068595
Brand
Protégé EverFlex™
Company
EV3, INC
Model
PRB35-05-100-080
Device description
STENT PRB35-05-100-080 PROTEGE EF V08
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGECATHETER, BILIARY, DIAGNOSTIC
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2
NIPStent, Superficial Femoral ArteryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K0723010005MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05Ev3, Inc.2008-03-18FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821684068595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821684068595008216840685958216840685950821684068595

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
Length100Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
117446916
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169996090TrailBlazer™SC-014-1352017-10-15
00643169996106TrailBlazer™SC-014-1502017-10-15
00643169996113TrailBlazer™SC-018-0902017-10-15
00643169996120TrailBlazer™SC-018-1352017-10-15
00643169996137TrailBlazer™SC-018-1502017-10-15
00643169996144TrailBlazer™SC-035-0652017-10-15
00643169996151TrailBlazer™SC-035-0902017-10-15
00643169996168TrailBlazer™SC-035-1352017-10-15
00643169996175TrailBlazer™SC-035-1502017-10-19
00763000104740TrailBlazer™SC-014-1352019-02-28
00763000104757TrailBlazer™SC-014-1502019-02-28
00763000104764TrailBlazer™SC-018-0902019-02-28
00763000104771TrailBlazer™SC-018-1352019-02-28
00763000104788TrailBlazer™SC-018-1502019-02-28
00763000104795TrailBlazer™SC-035-0652019-02-28
00763000104801TrailBlazer™SC-035-0902019-02-28
00763000104818TrailBlazer™SC-035-1352019-02-28
00763000104825TrailBlazer™SC-035-1502019-02-28
00821684057971TrailBlazer™SC-014-1352016-04-04
00821684057988TrailBlazer™SC-014-1502016-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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15711055003244M-DrainMermaid Medical A/SFGE2026-09-04
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