FDA.reportPublic FDA data

Boston Scientific Channel Steerable Sheath

Primary DI
08714729862413
Brand
Boston Scientific Channel Steerable Sheath
Company
Greatbatch Ltd
Model
M004CS100
Catalog number
M004CS100
Device description
Channel Steerable Sheath, 8 French
Published
2016-09-24
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

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729862413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729862413087147298624138714729862413

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0
Device Size Text, specify0
Length0
Lumen/Inner Diameter0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Regulatory Flags#

DUNS number
968623467
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821329000416Greatbatch Steerable Sheath10876-00110876-0012017-10-19
00821329000423Greatbatch Steerable Sheath10876-00210876-0022017-10-19
00821329000669Boston Scientific Channel Steerable SheathM004CS200M004CS2002018-02-06
00821329401008MOBICATH™D140011D1400112018-02-06
08714729862420Boston Scientific Channel Steerable SheathM004CS200M004CS2002016-09-24
00846835012371MobiCath™D140011D1400112016-09-24
00846835012388MobiCath™D140010D1400102016-09-24
00821329000652Boston Scientific Channel Steerable SheathM004CS100M004CS1002018-02-06
00821329400995MOBICATH™D140010D1400102018-02-06
00821329601491Greatbatch Steerable Sheath10876-00110876-0012016-09-24
00821329601507Greatbatch Steerable Sheath10876-00210876-0022016-09-24
00821329580499Algovita®5208-20-USA5208-202015-12-01
00821329580505Algovita®5208-40-USA5208-402015-12-01
00821329580512Algovita®5208-60-USA5208-602015-12-01
00821329580529Algovita®5212-20-USA5212-202015-12-01
00821329580536Algovita® 5212-40-USA5212-402015-12-01
00821329580543Algovita® 5212-60-USA5212-602015-12-01
00821329900204Myopore® Sutureless Myocardial Pacing Lead5112102015-05-21
00821329900228Myopore® Sutureless Myocardial Pacing Lead5112122015-05-21
00821329900211Myopore® Sutureless Myocardial Pacing Lead5112112015-05-21

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