PTFE Peelable Introducer Kit

Primary DI
00821329000355
Brand
PTFE Peelable Introducer Kit
Company
Greatbatch Ltd
Model
667091-351
Catalog number
7091
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10821329000352PackageGS11In Commercial Distribution
00821329000355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082132900035210821329000352
00821329000355008213290003558213290003550821329000355

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 Gauge8French
Device Size Text, specify0
Length14Centimeter
Length60Centimeter
Length70Millimeter
Lumen/Inner Diameter0.9Millimeter
Lumen/Inner Diameter2.7Millimeter
Needle Gauge18Gauge
Outer Diameter0.89Millimeter
Outer Diameter2.9Millimeter
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
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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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00821329000331PTFE Peelable Introducer Kit667087-35170872017-10-26
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00821329000447RadialSeal™ Introducer Kit, SS WireSPC-000653-0092018-09-24
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00821329000485RadialSeal™ Introducer Kit, Poly WireSPC-000654-0092018-09-24