EndoTGrasper ET2021

GUDID 10816207020331

Endoscopic retrieval device

ENDO-THERAPEUTICS, INC.

Gastrointestinal/airway foreign body retrieval basket

• Primary Device ID: 10816207020331
• NIH Device Record Key: e2e5b8c5-26e9-464c-b81b-8f4674bad682
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoTGrasper
• Version Model Number: ET2021
• Catalog Number: ET2021
• Company DUNS: 825239189
• Company Name: ENDO-THERAPEUTICS, 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: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com

Device Dimensions

• Length: 150 Centimeter
• Length: 150 Centimeter
• Length: 150 Centimeter
• Length: 150 Centimeter
• Length: 150 Centimeter
• Length: 150 Centimeter
• Length: 150 Centimeter
• Length: 150 Centimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 150 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816207020334 [Primary]
GS1	10816207020331 [Package]; Contains: 00816207020334; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800972

FDA Product Code

• OCZ: Endoscopic Grasping/Cutting Instrument, Non-Powered

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: 2019-11-05
• Device Publish Date: 2016-09-22

On-Brand Devices [EndoTGrasper]

• 10816207020348: Endoscopic retrieval device
• 10816207020331: Endoscopic retrieval device
• 10816207020959: Endoscopic Retrieval Device