GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
GLIDESHEATH SLENDER - RM*ES5J16HAT
Device Description
A 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.
Environmental Conditions
- Fragile. Keep dry. Keep away from sunlight. Stacking limit by 11.
Device Sizes
- Length: 16 Centimeter
- Those Clinically Relevant Size are relative to the sheath.
- Lumen/Inner Diameter: 1.78 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DYB
Device Name: Introducer, Catheter
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1340
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 34987350722622
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04987350722621
Package Quantity: 5
Package Discontinue Date: 7/31/2018 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Shelfbox
Device Id: 04987350722621
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 54987350722626
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 34987350722622
Package Quantity: 4
Package Discontinue Date: 7/31/2018 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Carton