Histolock 00711871

GUDID 10724995182875

The Histolock resection device is an electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.

US Endoscopy

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 10724995182875
• NIH Device Record Key: 22e94f6b-d25d-45f1-9171-7c36363f21ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Histolock
• Version Model Number: 00711871
• Catalog Number: 00711871
• 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: 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
• 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 Dimensions

• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 14 Millimeter
• Outer Diameter: 2.4 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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	00724995182878 [Primary]
GS1	00816765012826 [Previous]
GS1	10724995182875 [Package]; Contains: 00724995182878; Package: Box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140763

FDA Product Code

• FDI: SNARE, FLEXIBLE

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: 2020-04-10
• Device Publish Date: 2020-04-02

On-Brand Devices [Histolock]

• 10816765012847: The Histolock resection kit (5-piece) contains the devices needed for injecting, resecting, and
• 10816765012830: The Histolock resection kit (4 piece) contains the devices needed for injecting, resecting, and
• 10816765012823: The Histolock resection device is an electrosurgical device designed to be used to endoscopicall
• 10816765012724: The Histolock resection device is an electrosurgical device designed to be used to endoscopicall
• 10724995182899: The Histolock resection kit (5-piece) contains the devices needed for injecting, resecting, and
• 10724995182882: The Histolock resection kit (4-piece) contains the devices needed for injecting, resecting, and
• 10724995182875: The Histolock resection device is an electrosurgical device designed to be used to endoscopicall