Biopsy Forceps - Hot SG-111-622H

GUDID 10816207020591

Electrosurgical endoscopic biopsy device

ENDO-THERAPEUTICS, INC.

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 10816207020591
• NIH Device Record Key: 6ad38002-50db-475b-9cbf-836213f9524d
• Commercial Distribution Discontinuation: 2019-11-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Biopsy Forceps - Hot
• Version Model Number: SG-111-622H
• Catalog Number: SG-111-622H
• 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

Device Dimensions

• Length: 230 Centimeter
• Length: 230 Centimeter
• Length: 230 Centimeter
• Length: 230 Centimeter
• Length: 230 Centimeter
• Length: 230 Centimeter
• Length: 230 Centimeter
• Length: 230 Centimeter
• Length: 230 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816207020594 [Primary]
GS1	10816207020591 [Package]; Contains: 00816207020594; Package: box [10 Units]; Discontinued: 2019-11-04; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800973

FDA Product Code

• KNS: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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 [Biopsy Forceps - Hot]

• 10816207020607: Electrosurgical endoscopic biopsy forceps with needle
• 10816207020591: Electrosurgical endoscopic biopsy device
• 10816207020584: Electrosurgical endoscopic biopsy forceps with Needle
• 10816207020577: Electrosurgical endoscopic biopsy forceps