FDA.reportPublic FDA data

PTFE Peelable Introducer Kit

Primary DI
00821329000546
Brand
PTFE Peelable Introducer Kit
Company
Greatbatch Ltd
Model
667097-351
Catalog number
7097
Published
2017-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10821329000543PackageGS11In Commercial Distribution
00821329000546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082132900054310821329000543
00821329000546008213290005468213290005460821329000546

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge11French
Device Size Text, specify0
Length14Centimeter
Length60Centimeter
Length70Millimeter
Lumen/Inner Diameter0.9Millimeter
Lumen/Inner Diameter3.7Millimeter
Needle Gauge18Gauge
Outer Diameter0.89Millimeter
Outer Diameter3.9Millimeter
Total Volume12Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
968623467
Device count
1
Kit
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
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
08714729862413Boston Scientific Channel Steerable SheathM004CS100M004CS1002016-09-24
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03
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06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
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10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27