FDA.reportPublic FDA data

Torque Device for Guidewire

Primary DI
06936775511554
Brand
Torque Device for Guidewire
Company
Amsinomed Medical Co.,Ltd
Model
MZCH-2-12
Published
2023-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936775511554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936775511554069367755115546936775511554

GMDN Terms#

Term, Definition table
TermDefinition
Torque manipulation deviceA sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545137135
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936775511486Torque Device for GuidewireMZCH-1-52023-04-18
06936775511493Torque Device for GuidewireMZCH-1-82023-04-18
06936775511509Torque Device for GuidewireMZCH-1-102023-04-18
06936775511516Torque Device for GuidewireMZCH-1-122023-04-18
06936775511523Torque Device for GuidewireMZCH-2-52023-04-18
06936775511530Torque Device for GuidewireMZCH-2-82023-04-18
06936775511547Torque Device for GuidewireMZCH-2-102023-04-18
06936775511561Torque Device for GuidewireMZCH-3-82023-04-18
06936775511578Torque Device for GuidewireMZCH-3-102023-04-18
06936775511585Torque Device for GuidewireMZCH-3-122023-04-18

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