Ascendo 00712934

GUDID 20724995221618

Ascendo Submucosal Lifting Agent

US Endoscopy

Submucosal lift solution/gel

• Primary Device ID: 20724995221618
• NIH Device Record Key: c6e3f3e3-5446-4396-b316-eec6f8f8581f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascendo
• Version Model Number: 00712934
• Catalog Number: 00712934
• Company DUNS: 627879687
• Company Name: US Endoscopy
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995221614 [Primary]
GS1	10724995221611 [Package]; Contains: 00724995221614; Package: Box [10 Units]; In Commercial Distribution
GS1	20724995221618 [Package]; Contains: 10724995221611; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220434

FDA Product Code

• PLL: Submucosal injection agent

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: 2023-07-19
• Device Publish Date: 2023-07-11

Devices Manufactured by US Endoscopy

• 00724995199302 - truFreeze: 2024-12-03 truFreeze Spray Cryotherapy Console - Evaluation Unit
• 10724995220058 - Roth Net: 2024-12-03 The Roth Net retriever-360 product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and ca
• 10724995220065 - Roth Net Platinum: 2024-12-03 The disposable Roth Net Platinum universal retrieval device product line is used in the endoscopic retrieval of foreign body, fo
• 00724995228897 - CO2MPACT: 2024-12-03 CO2MPACT EVALUATION KIT. The CO2MPACT Endoscopic Insufflator System is designed to use CO2 as a distention media in the gastroin
• 10724995231719 - DEFENDO: 2024-12-03 The single-use DEFENDO Olympus EUS Air Water Suction , Biopsy valve - 3-piece kit is used to control the air/water function of a
• 00724995226732 - Padlock Clip: 2024-11-08 The Padlock Clip EFTR Kit includes the EFTR Device, Raptor grasping device, and (TouchSoft Coagulator Probe.
• 10724995197688 - DEFENDO: 2024-07-23 The single-use DEFENDO Olympus EUS Air Water Suction valve - 2-piece kit is used to control the air/water function of an endosco
• 10724995217409 - DEFENDO: 2024-07-23 The single-use DEFENDO Olympus EUS Air Water Suction Valve - Linear Biopsy Valve 3-piece kit