ESPINER MEDICAL RETRIEVAL SYSTEM

GUDID 5060358121531

Laparoscopic tissue retrieval sac for use with minimally invasive procedures

ESPINER MEDICAL LIMITED

Tissue extraction bag Tissue extraction bag

• Primary Device ID: 5060358121531
• NIH Device Record Key: ce20f00e-4a40-4e3f-87b2-249f681a6890
• Commercial Distribution Discontinuation: 2019-07-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ESPINER MEDICAL RETRIEVAL SYSTEM
• Version Model Number: EMP240ECO-US
• Company DUNS: 774603880
• Company Name: ESPINER MEDICAL LIMITED
• 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: 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: 1-508-3848490
• Email: bbarrett@globalmedllc.com
• Phone: 1-508-3848490
• Email: bbarrett@globalmedllc.com

Device Dimensions

• Total Volume: 3650 Milliliter
• Total Volume: 3650 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060358121951 [Primary]
GS1	5060358121531 [Package]; Contains: 05060358121951; Package: BOX [5 Units]; Discontinued: 2019-07-08; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111845

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: 4
• Public Version Date: 2019-07-09
• Device Publish Date: 2016-09-23

Devices Manufactured by ESPINER MEDICAL LIMITED

• 05060358120381 - ESPINER TISSUE RETRIEVAL SYSTEM: 2023-05-23 Laparoscopic tissue retrieval sac for use with minimally invasive procedures.
• 05060358120954 - ESPINER TISSUE RETRIEVAL SYSTEM: 2019-07-10 Laparoscopic tissue retrieval sac for use with minimally invasive procedures.
• 5060358120015 - ESPINER TISSUE RETRIEVAL SYSTEM: 2019-07-10 Laparoscopic tissue retrieval sac for use with minimally invasive procedures.
• 5060358120046 - ESPINER TISSUE RETRIEVAL SYSTEM: 2019-07-10 Laparoscopic tissue retrieval sac for use with minimally invasive procedures.
• 5060358120190 - ESPINER TISSUE RETRIEVAL SYSTEM: 2019-07-10 Laparoscopic tissue retrieval sac for use with minimally invasive procedures.
• 5060358121289 - ESPINER TISSUE RETRIEVAL SYSTEM: 2019-07-10 Laparoscopic tissue retrieval sac for use with minimally invasive procedures.
• 5060358121296 - ESPINER TISSUE RETRIEVAL SYSTEM: 2019-07-10 Laparoscopic tissue retrieval sac for use with minimally invasive procedures.
• 5060358120121 - ESPINER TISSUE RETRIEVAL SYSTEM: 2019-07-10 Laparoscopic tissue retrieval sac for use with minimally invasive procedures.