LEEP REDIKIT

GUDID 00888937000030

LOOP Electrosurgical Excision Procedure (Contains Lidocaine with Epinephrine)

Coopersurgical, Inc.

Cervical anaesthesia kit Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use Cervical anaesthesia needle, single-use

• Primary Device ID: 00888937000030
• NIH Device Record Key: af6b43a9-b3df-4b32-a9ac-15130061b3cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEEP REDIKIT
• Version Model Number: 6061
• 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: 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	00888937000030 [Primary]
GS1	20888937000034 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910253

FDA Product Code

• HEE: Set, Anesthesia, Paracervical

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: 2016-02-02

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