Auto-Band®

GUDID 00816849010021

Ligator Assembly & Band Barrel w/7 Latex Bands

ENDOCHOICE, INC.

Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use

• Primary Device ID: 00816849010021
• NIH Device Record Key: 12b0f499-fe20-489b-97e2-5cacf1a887c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Auto-Band®
• Version Model Number: DBL-358
• Company DUNS: 014154279
• Company Name: ENDOCHOICE, 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com
• Phone: 888-632-3636
• Email: customercare@endochoice.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816849010021 [Primary]

FDA Product Code

• MND: Ligator, Esophageal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-21
• Device Publish Date: 2016-09-08

On-Brand Devices [Auto-Band®]

• 00816849010038: Ligator Assembly & Band Barrel w/7 non-Latex Bands
• 00816849010021: Ligator Assembly & Band Barrel w/7 Latex Bands
• 00816849010014: Ligator Assembly & Band Barrel w/7 Latex Bands
• 00816849010007: Ligator Assembly & Band Barrel w/7 non-Latex Bands