GelPOINT® Path Transanal Access Platform

GUDID 00607915134440

Transanal Access Platform

APPLIED MEDICAL RESOURCES CORPORATION

Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use

• Primary Device ID: 00607915134440
• NIH Device Record Key: 1fb5cfe6-203b-4029-ba92-a82a8778b091
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GelPOINT® Path Transanal Access Platform
• Version Model Number: CNO11
• Company DUNS: 187129135
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• 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: 1.949.713.8300
• Email: contact@appliedmedical.com
• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com
• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com

Device Dimensions

• Length: 5.5 Centimeter
• Length: 5.5 Centimeter
• Length: 5.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607915134440 [Primary]
GS1	10607915134447 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• FER: Anoscope 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: 3
• Public Version Date: 2018-10-30
• Device Publish Date: 2016-09-23

On-Brand Devices [GelPOINT® Path Transanal Access Platform]

• 00607915134440: Transanal Access Platform
• 10607915127647: Transanal Access Platform