endomina system

GUDID 05425029282070

endomina system is composed of 1 endomina platform and 6 TAPES

Endo Tools Therapeutics

Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use

• Primary Device ID: 05425029282070
• NIH Device Record Key: b39e618f-d043-4da2-ba08-afb9a0016d0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: endomina system
• Version Model Number: endomina system
• Company DUNS: 400000750
• Company Name: Endo Tools Therapeutics
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05425029282070 [Primary]
GS1	05425029282971 [Package]; Package: Pallet [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211309

FDA Product Code

• OCW: Endoscopic Tissue Approximation Device

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: 2022-07-27
• Device Publish Date: 2022-07-19

Devices Manufactured by Endo Tools Therapeutics

• 05425029282117 - endomina platform: 2022-07-27 endomina platform primary packaging (x1)
• 05425029282070 - endomina system: 2022-07-27endomina system is composed of 1 endomina platform and 6 TAPES
• 05425029282070 - endomina system: 2022-07-27 endomina system is composed of 1 endomina platform and 6 TAPES
• 05425029282698 - TAPES: 2022-07-27 TAPES primary packaging (x1)