Boston Scientific Channel Steerable Sheath M004CS200

GUDID 08714729862420

Channel Steerable Sheath, 9 French

Greatbatch Ltd

Vascular guide-catheter, single-use

Primary Device ID	08714729862420
NIH Device Record Key	bfe96609-2fde-478b-9bb0-98f57a6b46a6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Boston Scientific Channel Steerable Sheath
Version Model Number	M004CS200
Catalog Number	M004CS200
Company DUNS	968623467
Company Name	Greatbatch Ltd
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree
Device Size Text, specify	0
Length	86 Centimeter
Lumen/Inner Diameter	0.9 Millimeter
Outer Diameter	3.3 Millimeter
Length	67 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	4.2 Millimeter
Angle	180 degree

Operating and Storage Conditions

Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729862420 [Primary]

FDA Product Code

DQY	Catheter, Percutaneous

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	7
Public Version Date	2019-09-20
Device Publish Date	2016-09-24

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