FDA.reportPublic FDA data

Malleable Suction Tube

Primary DI
04946329349634
Brand
Malleable Suction Tube
Company
MIZUHO CORPORATION
Model
07-794-94
Catalog number
07-794-94
Device description
Malleable Suction Tube, 9Fr, Str, SUS
Published
2020-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04946329349634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04946329349634049463293496344946329349634

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length209Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999regulatory@mizuho.co.jp

Regulatory Flags#

DUNS number
690677802
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04946329189582Sugita Titanium Clip II Case17-010-8017-010-802022-04-05
04946329206470Sugita Clip Case07-936-6007-936-602022-04-05
04946329376289Sugita Clip Metal Case07-936-6607-936-662022-02-03
04946329376296Sugita Titanium Clip II Metal Case17-010-2017-010-202022-02-03
04946329067682U-shaped Head Rest08-073-0308-073-032021-07-02
04946329067699U-shaped Head Rest08-073-0408-073-042021-07-02
04946329173932Operating Table VACB-3006B08-041-2008-041-202025-09-05
04946329308259Operating Table VACB-3006B Type150S08-055-7508-055-752025-09-05
04946329385847Narrow head section08-075-0008-075-002025-09-05
04946329385854Narrow head section08-083-6908-083-692025-09-05
04946329385861Narrow head section08-083-7008-083-702025-09-05
04946329404555Operating Table MST-7300BX18-045-1418-045-142025-09-05
04946329058291CP ANGLED SUPER MICRO-DISSECTORS07-821-0507-821-052022-04-17
04946329443066Side Rail Clamp (18 mm)08-110-1808-110-182025-06-26
04946329404234Short Boot Extender18-070-5018-070-502025-06-10
04946329416725SUGITA TITANIUM ANEURYSM CLIP II17-002-4017-002-402025-04-25
04946329416732SUGITA TITANIUM ANEURYSM CLIP II17-002-4117-002-412025-04-25
04946329416749SUGITA TITANIUM ANEURYSM CLIP II17-002-4217-002-422025-04-25
04946329416756SUGITA TITANIUM ANEURYSM CLIP II17-002-4317-002-432025-04-25
04946329416763SUGITA TITANIUM ANEURYSM CLIP II17-002-4417-002-442025-04-25

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