Assurance 00711883

GUDID 10724995190528

The Assurance Clip - 13mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purpose of mechanical pressure treatment of bleeding of small arteries and pulsation.

US Endoscopy

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

• Primary Device ID: 10724995190528
• NIH Device Record Key: 4ef6f63c-d1f3-4a9d-a5f5-800c06be6936
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assurance
• Version Model Number: 00711883
• Catalog Number: 00711883
• Company DUNS: 627879687
• Company Name: US Endoscopy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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(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	00724995190521 [Primary]
GS1	10724995190528 [Package]; Contains: 00724995190521; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172727

FDA Product Code

• PKL: Hemostatic metal clip for the GI tract

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: 2021-07-30
• Device Publish Date: 2021-07-22

On-Brand Devices [Assurance]

• 10724995215801: The Assurance Clip -16 mm is compatible with endoscopes and is indicated for clip placement with
• 10724995215795: The Assurance Clip - 9 mm is compatible with endoscopes and is indicated for clip placement with
• 10724995190528: The Assurance Clip - 13mm is compatible with endoscopes and is indicated for clip placement with
• 10724995190511: The Assurance Clip - 11 mm is compatible with endoscopes and is indicated for clip placement wit
• 10724995219175: The Assurance Control Clip - 16 mm is compatible with endoscopes and is indicated for clip place
• 10724995219168: The Assurance Control Clip - 11 mm is compatible with endoscopes and is indicated for clip place
• 10724995219151: The Assurance Clip - 18 mm is compatible with endoscopes and is indicated for clip placement wit
• 10724995220690: The Assurance Clip -16 mm is compatible with endoscopes and is indicated for clip placement with
• 50724995220681: The Assurance Clip - 11 mm is compatible with endoscopes and is indicated for clip placement wit