FDA.report

MEMO 3D

Primary DI
08022057014115
Brand
MEMO 3D
Company
SORIN GROUP ITALIA SRL
Model
SGTR-100
Published
2021-04-02
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
08022057014115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08022057014115080220570141158022057014115

GMDN Terms

TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. 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

Other Devices From This Company

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38033178102934DHF02 HEMOCONCENTRATOR2015-07-15
38033178102941DHF06 HEMOCONCENTRATOR2015-07-15
38033178233638SH14 - HEMOCONCENTRATOR2015-07-15
38033178019621Aortic Root cannulaAR-131142026-03-06
38033178019638Aortic Root cannulaAR-191142026-03-06
38033178019645Vessel CannulaVC-120002026-03-06
38033178019652Vessel CannulaVC-120102026-03-06
38033178019669Vessel CannulaVC-120202026-03-06
38033178019676Vessel CannulaVC-220102026-03-06
38033178017191Cardioplegia CannulaAR-110122026-02-11
38033178017207Cardioplegia CannulaAR-110142026-02-11
38033178017214Cardioplegia CannulaAR-110162026-02-11
38033178017221Cardioplegia CannulaAR-110182026-02-11
38033178017238Cardioplegia CannulaAR-111122026-02-11
38033178017245Cardioplegia CannulaAR-111142026-02-11
38033178017252Cardioplegia CannulaAR-111162026-02-11
38033178017269Cardioplegia CannulaAR-170122026-02-11
38033178017276Cardioplegia CannulaAR-170142026-02-11
38033178017313Cardioplegia CannulaAX-303212026-02-11
38033178018075Coronary Sinus CannulaRCM-141152026-02-11

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