PTFE Peelable Introducer Kit

Basic Information

• Brand Name: PTFE Peelable Introducer Kit
• Primary DI: 00821329000522
• Version / Model: 667090-351
• Catalog Number: 7090
• Company Name: Greatbatch Ltd
• Labeler DUNS: 968623467
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-26
• Public Version: 3
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: ad74cd97-37b3-42a4-95f4-f3c1afa13299

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10821329000529	GS1	box	1	In Commercial Distribution
Primary	00821329000522	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Needle Inner Diameter: 0.9 mm
Outer Diameter	0.89	Millimeter
Length	70	Millimeter
Lumen/Inner Diameter	2.6	Millimeter
Total Volume	12	Milliliter
Needle Gauge	18	Gauge
Length	60	Centimeter
Outer Diameter	2.8	Millimeter
Catheter Gauge	7.5	French
Lumen/Inner Diameter	0.9	Millimeter
Length	14	Centimeter

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: – 40 Degrees Celsius