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Boston Scientific Channel Steerable Sheath

FDA UDI

Class II (US FDA UDI)

by Greatbatch Ltd

Identity

Trade Name
Boston Scientific Channel Steerable Sheath FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
Channel Steerable Sheath, 8 French FDA UDI
Model / Reference
M004CS100 FDA UDI
Description
Channel Steerable Sheath, 8 French FDA UDI

Identifiers

Catalog Number
M004CS100 FDA UDI
Primary DI / UDI-DI
00821329000652 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 86 Centimeter FDA UDI
Outer Diameter — 2.8 Millimeter FDA UDI
Lumen/Inner Diameter — 0.9 Millimeter FDA UDI
Length — 67 Centimeter FDA UDI
Outer Diameter — 3.8 Millimeter FDA UDI
Lumen/Inner Diameter — 2.5 Millimeter FDA UDI
Angle — 180 degree FDA UDI

Boston Scientific Channel Steerable Sheath by Greatbatch Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Greatbatch Ltd

Sources (1)

  • FDA UDI f25f0475-2178-41ca-9636-64c4072ce783 36 fields · synced Jun 8, 2026