FDA.reportPublic FDA data

Percuflex™ Plus

Primary DI
08714729774211
Brand
Percuflex™ Plus
Company
BOSTON SCIENTIFIC CORPORATION
Model
M006175251190
Device description
Ureteral Stent Set
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FADSTENT, URETERAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FADStent, UreteralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729774211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729774211087147297742118714729774211

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric ureteral stentA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), 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. The device is typically intended for long-term, but not permanent, implantation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450721206ReSolve ConvertX®Merit Medical Systems, Inc.FAD2026-03-05
10884450721176ReSolve ConvertX®Merit Medical Systems, Inc.FAD2026-02-05
08714729058632Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729058953Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729297253Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729297352Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729297611Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729339830Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729424123Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729424222Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729765370Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729765684Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729766421Polaris™ UltraBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729766575Polaris™ UltraBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729766582Polaris™ UltraBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729774129Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729774617Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729774648Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729775997Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776017Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776116Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776321Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776352Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776574Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776949Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777465Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777540Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777601Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777663Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777670Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24