FDA.report

26 MM X 3CM X 110CM RETROFLEX DELIVERY SYSTEM

Primary DI
00690103181999
Brand
26 MM X 3CM X 110CM RETROFLEX DELIVERY SYSTEM
Company
Edwards Lifesciences LLC
Model
9120FS26
Catalog number
9120FS26
Published
2014-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NPTAortic valve, prosthesis, percutaneously delivered

Product Code Classifications

CodeDeviceSpecialtyClass
NPTAortic Valve, Prosthesis, Percutaneously DeliveredUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00690103181999PrimaryGS10

GMDN Terms

TermDefinition
Catheter introducerA sterile tubular plastic sheath designed to be percutaneously placed into a natural body space (e.g., vein, artery, ventricle, peritoneal cavity), or an artificial passageway (e.g., created by means of a catheter tunneller), and through which a catheter is subsequently inserted (by pushing) for placement. It typically has a handle (e.g., T-shaped wing grips) at the proximal end, and may have radiopaque graduated markings at the working end to make it visible on x-ray. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)822-9837tech_support@edwards.com

Regulatory Flags

DUNS number
134139174
Device count
1
Premarket exempt
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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

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57460691952770TRUWAVEPXMK1077PXMK10772026-03-20
57460691955887TRUWAVEPXMK1780PXMK17802026-03-20
00690103000382SWAN-GANZ TRUE SIZE123F6123F6P2026-03-16
50690103218287SWAN-GANZ VIP831F75831F75P2026-03-16
50690103218607SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
50690103218621SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
50690103218638SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103221312Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL20A9631PL20A2026-02-17
00690103221329Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL23A9631PL23A2026-02-17
00690103221336Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL26A9631PL26A2026-02-17
00690103221343Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL29A9631PL29A2026-02-17
00690103019353AORTIC TRUE-SIZE OBTURATOR 19MM1161116119MM2026-02-13
00690103019360AORTIC TRUE-SIZE OBTURATOR 21MM1161116121MM2026-02-13
00690103019377AORTIC TRUE-SIZE OBTURATOR 23MM1161116123MM2026-02-13
00690103019384AORTIC TRUE-SIZE OBTURATOR 25MM1161116125MM2026-02-13
00690103019391AORTIC TRUE-SIZE OBTURATOR 27MM1161116127MM2026-02-13
00690103019407AORTIC TRUE-SIZE OBTURATOR 29MM1161116129MM2026-02-13
00690103019414AORTIC TRUE-SIZE OBTURATOR 31MM1161116131MM2026-02-13
00690103019278HEART VALVE SIZER ACCESSORY1127112723MM2026-02-11
00690103019285HEART VALVE SIZER ACCESSORY1127112725MM2026-02-11

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