Wallach EndoBlock Needle

GUDID 20888937011207

Endocervical Block Needle with Luer Lock Hub

Coopersurgical, Inc.

Cervical anaesthesia needle, single-use

• Primary Device ID: 20888937011207
• NIH Device Record Key: a845a0cb-ae5a-4b4b-a870-6ff43369625f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wallach EndoBlock Needle
• Version Model Number: 920017
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20888937011207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021224

FDA Product Code

• HEE: Set, Anesthesia, Paracervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Wallach EndoBlock Needle]

• 20888937011214: Endocervical Block Needle with Threaded Hub
• 20888937011207: Endocervical Block Needle with Luer Lock Hub