Potocky Needle®

GUDID 20888937010934

Potocky Needle® For Intra Cervical Block

Coopersurgical, Inc.

Cervical anaesthesia needle, single-use

• Primary Device ID: 20888937010934
• NIH Device Record Key: c4829df9-1c92-456b-804e-545036d2315e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Potocky Needle®
• Version Model Number: 6166
• 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: 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	20888937010934 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910252

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: 2016-09-28

On-Brand Devices [Potocky Needle®]

• 20888937010934: Potocky Needle® For Intra Cervical Block
• 20888937010927: Potocky Needle® For Intra Cervical Block