ATLAS Suture Delivery System ESD121-05-1, SD121-05-101, SD121-05-105

GUDID 00842071131180

ATLAS Suture Delivery System, 1-Pack (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Suture retention device Suture retention device Suture retention device Suture retention device Suture retention device Suture retention device Suture retention device Suture retention device Suture retention device Suture retention device Suture retention device Suture retention device Suture retention device Suture retention device Suture retention device Suture retention device

• Primary Device ID: 00842071131180
• NIH Device Record Key: 654b1329-6f6f-4e75-86d5-df1952c4d29b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLAS Suture Delivery System
• Version Model Number: ESD121-05-1
• Catalog Number: ESD121-05-1, SD121-05-101, SD121-05-105
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071131128 [Primary]
GS1	00842071131180 [Package]; Contains: 00842071131128; Package: Box (SD121-05-101) [1 Units]; In Commercial Distribution
GS1	00842071131197 [Package]; Contains: 00842071131128; Package: Box (SD121-05-105) [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193612

FDA Product Code

• KGC: Tube, Gastro-Enterostomy

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: 2021-11-23
• Device Publish Date: 2021-11-15

On-Brand Devices [ATLAS Suture Delivery System]

• 00842071131203: ATLAS Suture Delivery System, 2-Pack (Pouched)
• 00842071131180: ATLAS Suture Delivery System, 1-Pack (Pouched)