AMT Initial Placement Dilator Set IP-DIL-10

GUDID 00842071130602

AMT Initial Placement Dilator Set (10F)

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy procedure kit Gastrostomy procedure kit Gastrostomy procedure kit Gastrostomy procedure kit

• Primary Device ID: 00842071130602
• NIH Device Record Key: 2c7b2ab6-e371-49b6-9cb1-b5be20ed5a14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Initial Placement Dilator Set
• Version Model Number: IP-DIL-10
• Catalog Number: IP-DIL-10
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071130602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073034

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: 2020-11-10
• Device Publish Date: 2020-11-02

On-Brand Devices [AMT Initial Placement Dilator Set]

• 00842071106867: AMT Initial Placement Dilator Set
• 00842071130602: AMT Initial Placement Dilator Set (10F)
• 00842071131876: AMT Initial Placement Dilator Kit (Smaller Dia GW)