CrossWise

GUDID 00850021246082

Steerable Transseptal Sheath

KALILA MEDICAL, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00850021246082
• NIH Device Record Key: 1346c242-144d-4a85-9743-4fbff6e1bdb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CrossWise
• Version Model Number: CW-STS8F25
• Company DUNS: 015986592
• Company Name: KALILA MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850021246082 [Primary]

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-09
• Device Publish Date: 2022-02-01

Devices Manufactured by KALILA MEDICAL, INC.

• 00850021246082 - CrossWise: 2022-02-09Steerable Transseptal Sheath
• 00850021246082 - CrossWise: 2022-02-09 Steerable Transseptal Sheath
• 00861705000425 - Nagare: 2020-03-05 Steerable Sheath, Bi-Directional
• 00810591020215 - Vado: 2020-03-05 Steerable Sheath, Unidirectional (140 degrees)
• 00810591020222 - Vado: 2020-03-05 Steerable Sheath, Bidirectional
• 00810591020239 - Vado: 2020-03-05 Steerable Sheath, Unidirectional (200 degrees)