ASAHI Gaia PV18

Primary DI: 14547327106877
Brand: ASAHI Gaia PV18
Company: ASAHI INTECC CO., LTD.
Model: PHW18R102P
Published: 2016-09-16
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: true
Single use: true

Related Records

Product Codes

Code	Name
DQX	WIRE, GUIDE, CATHETER

Product Code Classifications

Code	Device	Specialty	Class
DQX	Wire, Guide, Catheter	Cardiovascular	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
14547327106877	Package	GS1	5	In Commercial Distribution
04547327106870	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
14547327106877	14547327106877
04547327106870	04547327106870	4547327106870

GMDN Terms

Term	Definition
Peripheral vascular guidewire, manual	A long, thin, sterile wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Term

Definition

Peripheral vascular guidewire, manual

A long, thin, sterile wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes

Type	Value	Unit
Length	200	Centimeter
Outer Diameter	0.018	Inch

Sterilization Methods

Method

Regulatory Flags

DUNS number: 690711189
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: false
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: false
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

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