Non-Balloon Removal Tool

GUDID 00842071105136

14F x 3.0-3.3cm Non-Balloon Removal Tool

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy button

• Primary Device ID: 00842071105136
• NIH Device Record Key: 16aaf942-77f1-446f-a56b-6574bd7e3175
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Balloon Removal Tool
• Version Model Number: R-S3033
• 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

Device Dimensions

• Catheter Gauge: 14 French
• Catheter Gauge: 14 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071105136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980305

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-24

On-Brand Devices [Non-Balloon Removal Tool]

• 00842071105204: 18-24F x 4.0-4.4cm Non-Balloon Removal Tool
• 00842071105198: 18-24F x 3.4-3.7cm Non-Balloon Removal Tool
• 00842071105181: 18-24F x 3.0-3.3cm Non-Balloon Removal Tool
• 00842071105174: 18-24F x 2.4-2.7cm Non-Balloon Removal Tool
• 00842071105167: 18-24F x 2.0-2.3cm Non-Balloon Removal Tool
• 00842071105150: 18-24F x 1.5-1.7cm Non-Balloon Removal Tool
• 00842071105143: 18-24F x 1.0-1.2cm Non-Balloon Removal Tool
• 00842071105136: 14F x 3.0-3.3cm Non-Balloon Removal Tool
• 00842071105129: 14F x 2.4-2.7cm Non-Balloon Removal Tool
• 00842071105112: 14F x 2.0-2.3cm Non-Balloon Removal Tool
• 00842071105105: 14F x 1.5-1.7cm Non-Balloon Removal Tool
• 00842071105099: 14F x 1.0-1.2cm Non-Balloon Removal Tool