Histolock 00711117

GUDID 10724995182622

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

STERIS CORPORATION

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 10724995182622
• NIH Device Record Key: 0c5d80fd-5b51-4a79-887b-c2bf0d7e673c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Histolock
• Version Model Number: 00711117
• Catalog Number: 00711117
• Company DUNS: 139424188
• Company Name: STERIS CORPORATION
• 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
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Width: 14 Millimeter
• Length: 230 Centimeter
• 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	00724995182625 [Primary]
GS1	00816765012727 [Previous]
GS1	10724995182622 [Package]; Contains: 00724995182625; Package: Case [10 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: 2020-03-27
• Device Publish Date: 2020-03-19

Devices Manufactured by STERIS CORPORATION

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• 00724995203214 - HarmonyAIR: 2025-01-28 HarmonyAIR E-Series High Density Dual Light, Dual Flat Panel Monitor is used with the HarmonyAIR E-Series Lighting System.
• 10724995231504 - CELERITY: 2025-01-21 Celerity HP Indicator Tape
• 00724995222017 - NA: 2024-12-03 Foot Extension with Siderail Locks, Velcro without Pad is used with the 7000 Series Surgical Table.
• 00724995222024 - NA: 2024-12-03 Foot Extension with Siderail Locks, Velcro with 2-inch TLT Pad is used with the 7000 Series Surgical Tables.
• 00724995222048 - NA: 2024-12-03 Bariatric Foot Extension withSiderail Locks, Velcro with 2-inch TLT Pad is used with the 7000 Series Surgical Table.
• 00724995222260 - NA: 2024-12-03 2-inch TLT Pad, Velcro, Foot Extension, is used with the 7000 Series Surgical Tables.
• 00724995222277 - NA: 2024-12-03 3-inch TLT Pad, Velcro, Foot Extension, is used with the 7000 Series Surgical Tables.