FDA.report

UNI HANDLE

Primary DI
08022057014474
Brand
UNI HANDLE
Company
SORIN GROUP ITALIA SRL
Model
ICV0664
Published
2021-04-01
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

Product Codes

CodeName
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08022057014474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08022057014474080220570144748022057014474

GMDN Terms

TermDefinition
Heart valve prosthesis sizer handleA hand-held manual surgical instrument intended to be used during cardiac valve repair or replacement as a handle to which an interchangeable valve sizer is attached to allow the surgeon to evaluate the valve opening (patient annulus) into which the appropriate sized annuloplasty ring or replacement valve will be implanted. The device is typically made of metal and/or plastic (e.g., polysulphone) and is straight and/or curved, rigid and/or flexible in design; this handle may also be connected to the valve or ring holder to assist implantation. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
428011907
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
false
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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38033178017313Cardioplegia CannulaAX-303212026-02-11
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