FDA.report

Amplatzer™ Talisman™

Primary DI
05415067033352
Brand
Amplatzer™ Talisman™
Company
ST. JUDE MEDICAL, INC.
Model
9-TDS-08F45-80
Catalog number
9-TDS-08F45-80
Device description
Delivery Sheath
Published
2021-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DQYCatheter, percutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05415067033352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05415067033352054150670333525415067033352

GMDN Terms

TermDefinition
Cardiac occluder delivery kitA collection of devices designed to implant a cardiac occluder (not included) for the non-surgical closure of cardiac defects. The collection may include a delivery catheter/sheath, dilator, loading device, delivery cable, and additional items for the intravascular delivery and deployment of a cardiac occluder. The devices are used in the treatment of cardiac disorders that may include atrial septal defects (ASD), ventricular septal defects (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge8French
Length80Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags

DUNS number
149818952
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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

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