FDA.report

Cassette Tray

Primary DI
04946329068221
Brand
Cassette Tray
Company
MIZUHO CORPORATION
Model
08-092-00
Catalog number
08-092-00
Device description
Cassette tray (339 x 288 mm)
Published
2022-04-15
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
GDCTable, Operating-Room, Electrical

Product Code Classifications

CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04946329068221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04946329068221049463290682214946329068221

GMDN Terms

TermDefinition
X-ray film cassette holderA device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).

Device Sizes

TypeValueUnit
Length605Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
9999999999regulatory@mizuho.co.jp

Regulatory Flags

DUNS number
690677802
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
false

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