FDA.report

PILLING

Primary DI
24026704714616
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN005371
Catalog number
351560
Device description
STONEY HEPARIN INJECTOR
Published
2020-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GDMNEEDLE, ASPIRATION AND INJECTION, REUSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14026704714619Direct MarkingGS10
24026704714616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1402670471461914026704714619
2402670471461624026704714616

GMDN Terms

TermDefinition
Vascular irrigation cannula, coronary artery, reusableA rigid or semi-rigid tube designed to be surgically inserted, temporarily, into a coronary artery to serve as a channel for the transport of fluid during a surgical intervention. It is typically intended for the infusion and/or perfusion of fluids in diagnostic and/or surgical procedures, such as cardiopulmonary bypass, and to help avoid ischemia. Insertion is typically achieved with the use of a removable stylet or trocar blade. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Length1.875Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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