PTFE Peelable Introducer Kit

Primary DI
00821329000331
Brand
PTFE Peelable Introducer Kit
Company
Greatbatch Ltd
Model
667087-351
Catalog number
7087
Published
2017-10-26
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10821329000338PackageGS11In Commercial Distribution
00821329000331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082132900033810821329000338
00821329000331008213290003318213290003310821329000331

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/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Device Size Text, specify0
Length0
Lumen/Inner Diameter0
Needle Gauge0
Outer Diameter0
Total Volume0

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
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00821329000317PTFE Peelable Introducer Kit1000558-00170872018-09-24
00821329000324PTFE Peelable Introducer Kit667088-35170882017-10-26
00821329000348PTFE Peelable Introducer Kit667089-35170892017-10-26
00821329000355PTFE Peelable Introducer Kit667091-35170912017-10-26
00821329000362PTFE Peelable Introducer Kit667093-35170932017-10-26
00821329000430RadialSeal™ Introducer Kit, SS WireSPC-000653-0072018-09-24
00821329000447RadialSeal™ Introducer Kit, SS WireSPC-000653-0092018-09-24
00821329000454RadialSeal™ Introducer Kit, SS WireSPC-000653-0082018-09-24
00821329000461RadialSeal™ Introducer Kit, Poly WireSPC-000654-0072018-09-24
00821329000478RadialSeal™ Introducer Kit, Poly WireSPC-000654-0082018-09-24
00821329000485RadialSeal™ Introducer Kit, Poly WireSPC-000654-0092018-09-24
00821329000508PTFE Peelable Introducer Kit667131-35171312017-10-26
00821329000515PTFE Peelable Introducer Kit667133-35171332017-10-26
00821329000522PTFE Peelable Introducer Kit667090-35170902017-10-26
00821329000539PTFE Peelable Introducer Kit667096-35170962017-10-26
00821329000546PTFE Peelable Introducer Kit667097-35170972017-10-26
00821329000553PTFE Peelable Introducer Kit667099-35170992017-10-26
00821329000676OptiSeal™1000092-0011000092-0012019-08-15
00821329000683OptiSeal™1000092-0021000092-0022019-08-15
00821329000690OptiSeal™1000092-0031000092-0032019-08-15

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Primary DI, Brand, Company table
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