Wallach

GUDID 20888937009297

Loop Electrode Size 0.8mm Diameter x 25.4mm Large Needle (12.7cm Shaft)

Coopersurgical, Inc.

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 20888937009297
• NIH Device Record Key: 1e5c7101-402e-462b-9598-507b2f0c12be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wallach
• Version Model Number: 909005
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937009293 [Primary]
GS1	20888937009297 [Package]; Contains: 00888937009293; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020711

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & 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: 2019-02-07
• Device Publish Date: 2016-05-25

On-Brand Devices [Wallach]

• 60888937011380: GYN LEEP Starter Kit
• 20888937011191: Endocervical Block Kit. Contents: 1 reinforced Luer Lock Needle, 1 18 gauge Luer Lock Needle and
• 50888937011185: Disposable Speculum Tubing for Smoke Evacuation Tubing
• 50888937010188: WALLACH® Disposable Vaginal Speculum Large
• 50888937010171: WALLACH® Disposable Vaginal Speculum Medium
• 50888937010164: WALLACH® Disposable Vaginal Speculum Small
• 50888937009885: Disposable Plastic Shields
• 20888937013775: WALLACH® Electrosurgical Pencil
• 00888937014037: WA4000 20# CO2 CONNECTOR
• 00888937014020: WA4000 20# N2O CONNECTOR
• 00888937014013: WA2000 6V DC W/Timer
• 00888937014006: Integration Unit (120 VAC)
• 00888937013993: Quantum 2000 Electrosurgical Generator (120 VAC)
• 00888937013986: Biovac Smoke Evacuator (120 VAC)
• 00888937013740: WALLACH® USB Video Conversion Kit
• 00888937013733: Trulight ZoomScope®
• 00888937013726: ZoomScope® with Trulight, USB
• 00888937013719: ZoomStar® with Trulight Colposcope with USB Video
• 00888937013702: ZoomStar® with Trulight Colposcope
• 00888937013696: ZoomScope® with Trulight Colposcope USB Video with 5-legged base
• 00888937013689: ZoomScope® with Trulight Colposcope with 5-legged base
• 00888937013672: ZoomScope® with Trulight Colposcope with 4-legged base
• 00888937013665: ZoomScope® with Trulight Colposcope with 3-legged base
• 00888937011371: Ultimate Reusable Vaginal Speculum
• 00888937009873: LL100 Two-Trigger Multi-Tip Cryosurgical System for N2O
• 00888937009866: LL100 Two-Trigger (with Thermocouple) Multi-Tip Cryosurgical System for N2O
• 00888937009828: LL-CO2 Multi-Tip Cryosurgical System (without Thermocouple)
• 00888937009811: LL-CO2 Multi-Tip Cryosurgical System (with Thermocouple)
• 00888937009804: LL-CO2 Multi-Tip Cryosurgical System (Pinned Yoke-CGA 940)
• 00888937009798: LLC-CO2 Multi-Tip Cryosurgical System (Hand Wheel-CGA 320)
• 20888937009419: Loop Electrode 5mm Ball (6cm Shaft)
• 20888937009402: Loop Electrode Size 0.8mm Diameter x 16mm Needle (5.5cm Shaft)
• 20888937009396: Loop Electrode 15mm x 5mm Loop
• 20888937009389: Loop Electrode 10mm x 7mm Loop
• 20888937009372: Loop Electrode 20mm x 10mm Loop
• 20888937009365: 10mm x 10mm Square
• 20888937009358: Loop Electrode 3mm Ball
• 20888937009341: Loop Electrode 10mm x 8mm Square
• 20888937009334: Loop Electrode 20mm x 8mm Loop
• 20888937009327: Loop Electrode 15mm x 8mm Loop
• 00888937009316: Loop Electrode 20mm x 15mm Loop
• 20888937009303: Loop Electrode 10mm x 10mm Loop
• 20888937009297: Loop Electrode Size 0.8mm Diameter x 25.4mm Large Needle (12.7cm Shaft)
• 20888937009280: Loop Electrode 5mm Ball
• 00888937002881: 15.0 mm HPV Cryosurgical Tip (T-1500) Sterilizable Cryotip
• 00888937002874: 13.5 mm HPV Cryosurgical Tip (T-1300) Sterilizable Cryotip
• 00888937002867: 9.0mm HPV Cryosurgical Tip (T-0900) Sterilizable Cryotip
• 00888937002850: 7.0 mm HPV Cryosurgical Tip (T-0700) Sterilizable Cryotip
• 00888937002843: 5.0 mm HPV Cryosurgical Tip (T-0500) Sterilizable Cryotip
• 00888937002836: 2.5mm HPV Cryosurgical Tip (T-0200) Sterilizable Cryotip