Abeon Guyuron E.A.D.

GUDID 00842071109882

Endoscopic Access Device (Box 10)

APPLIED MEDICAL TECHNOLOGY, INC.

Endoscope working-channel seal

• Primary Device ID: 00842071109882
• NIH Device Record Key: 8981b458-aa1b-427f-88da-669ccaae6c5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abeon Guyuron E.A.D.
• Version Model Number: ST8001
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 10
• 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
• 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
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071109325 [Unit of Use]
GS1	00842071109882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960232

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by APPLIED MEDICAL TECHNOLOGY, INC.

• 00842071145798 - MINI Balloon Button: 2025-11-24 12FR x 1.2 cm MINI Balloon Button Kit, MDR
• 00842071145804 - MINI Balloon Button: 2025-11-24 12FR x 1.2 cm MINI Balloon Button Kit (ENFit), MDR
• 00842071145897 - MINI Balloon Button: 2025-11-24 12FR x 2.5 cm MINI Balloon Button Kit, MDR
• 00842071145903 - MINI Balloon Button: 2025-11-24 12FR x 2.5 cm MINI Balloon Button Kit (ENFit), MDR
• 00842071145934 - MINI Balloon Button: 2025-11-24 12FR x 3.0 cm MINI Balloon Button Kit, MDR
• 00842071145941 - MINI Balloon Button: 2025-11-24 12FR x 3.0 cm MINI Balloon Button Kit (ENFit), MDR
• 00842071145972 - MINI Balloon Button: 2025-11-24 12FR x 4.0 cm MINI Balloon Button Kit, MDR
• 00842071145989 - MINI Balloon Button: 2025-11-24 12FR x 4.0 cm MINI Balloon Button Kit (ENFit), MDR