AMT Guidewire E4-GW-1, 4-GW-1

GUDID 00842071130633

Guidewire (.018"Dia x 45cm, pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use

• Primary Device ID: 00842071130633
• NIH Device Record Key: c121ad5f-50b7-496e-b6c3-c57542645d6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Guidewire
• Version Model Number: E4-GW-1
• Catalog Number: E4-GW-1, 4-GW-1
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071106911 [Primary]
GS1	00842071130633 [Package]; Contains: 00842071106911; Package: Box (4-GW-5) [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110804

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

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: 2022-06-30
• Device Publish Date: 2022-06-22

On-Brand Devices [AMT Guidewire]

• 00842071111823: Guidewire (.038"Dia x180cm, pouched)
• 00842071106942: Guidewire (.038"Dia x 90cm, pouched)
• 00842071106928: Guidewire (.018"Dia x 70cm, pouched)
• 00842071130633: Guidewire (.018"Dia x 45cm, pouched)