Wallach LL100

GUDID 60888937010079

Two-Trigger Multi-Tip Cryosurgical System for N2O

Coopersurgical, Inc.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 60888937010079
• NIH Device Record Key: b9ae72a7-7207-47a9-9bd3-2dddf828f8ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wallach LL100
• Version Model Number: 900001
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60888937010079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K803311

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-03

On-Brand Devices [Wallach LL100]

• 60888937010093: Two Trigger (with Thread Connect) Multi-Tip Cryosurgical System for N2O.
• 60888937010086: Two-Trigger (with Pinned Yoke) Multi-Tip Cryosurgical System for N20
• 60888937010079: Two-Trigger Multi-Tip Cryosurgical System for N2O