Gore TIPS Needle TNDL1656

GUDID 05391526210000

Gore TIPS Needle

CREGANNA UNLIMITED COMPANY

Portosystemic needle set

• Primary Device ID: 05391526210000
• NIH Device Record Key: 8775bdd8-1da8-4c81-80ab-4475d18e2ba1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gore TIPS Needle
• Version Model Number: TNDL1656
• Catalog Number: TNDL1656
• Company DUNS: 985218606
• Company Name: CREGANNA UNLIMITED COMPANY
• 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: false
• 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

Device Dimensions

• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge
• Needle Gauge: 16 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool place

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391526210000 [Primary]

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

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• 05391526210116 - Lotus™ Introducer Set: 2019-06-07 Lotus™ Introducer Set, Large
• 05391526210253 - Attain Assist™ CS Access Catheter: 2019-02-14 Attain Assist™ CS Access Catheter
• 05391526210031 - Zurpaz™ Steerable Sheath Set: 2019-01-23 Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath
• 05391526210048 - Zurpaz™ Steerable Sheath Set: 2019-01-23 Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath
• 05391526210055 - Zurpaz™ Steerable Sheath Set: 2019-01-23 Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath