Elliptical Basket, Medium BGE-1315M

GUDID 10816207020409

Endoscopic retrieval device, medium basket

ENDO-THERAPEUTICS, INC.

Gastrointestinal/airway foreign body retrieval basket

• Primary Device ID: 10816207020409
• NIH Device Record Key: 8f0b1dcc-c63c-4629-9bfa-abf9c30b6c35
• Commercial Distribution Discontinuation: 2019-11-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Elliptical Basket, Medium
• Version Model Number: BGE-1315M
• Catalog Number: BGE-1315M
• 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

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
• Length: 150 Centimeter
• Length: 150 Centimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 Millimeter
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 1.7 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816207020402 [Primary]
GS1	10816207020409 [Package]; Contains: 00816207020402; Package: box [10 Units]; Discontinued: 2019-11-04; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800970

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: 2016-09-20

On-Brand Devices [Elliptical Basket, Medium]

• 10816207020447: Endoscopic retrieval device, medium basket
• 10816207020423: Endoscopic retrieval device, medium basket
• 10816207020409: Endoscopic retrieval device, medium basket