ULTRATRACK Hybrid Guidewire 0.035" (0.89mm) x 150cm Regular Body, 3cm

GUDID 00821925031197

Gyrus Acmi, Inc.

Gastro-urological guidewire, single-use

• Primary Device ID: 00821925031197
• NIH Device Record Key: fc057104-728d-494e-a341-6b979f66f79c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRATRACK Hybrid Guidewire 0.035" (0.89mm) x 150cm Regular Body, 3cm
• Version Model Number: GWH3505RA
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00821925031197 [Package]; Contains: 00821925031432; Package: [5 Units]; In Commercial Distribution
GS1	00821925031432 [Primary]

FDA Product Code

• EYA: STYLET, URETERAL

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: 2018-10-15
• Device Publish Date: 2018-09-13

On-Brand Devices [ULTRATRACK Hybrid Guidewire 0.035" (0.89mm) x 150cm Regular Body, 3cm]

• 00821925031197: GWH3505RA
• 00821925031180: GWH3505R