Klein

GUDID 20841019110021

Disposable 10ft. (3m) Monopolar Endoscopic Cord

Klein Surgical Systems, Inc.

Electrical-only medical device connection cable, single-use

• Primary Device ID: 20841019110021
• NIH Device Record Key: a93de59a-82e8-479b-bea6-38b4dcb9d999
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klein
• Version Model Number: 3021-03
• Company DUNS: 072364974
• Company Name: Klein Surgical Systems, 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

Customer Support Contacts

• Phone: 781-834-9500
• Email: kprario@ksp.com

Device Dimensions

• Length: 10 Feet

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019110027 [Primary]
GS1	10841019110024 [Package]; Contains: 00841019110027; Package: [10 Units]; In Commercial Distribution
GS1	20841019110021 [Package]; Contains: 00841019110027; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913514

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[20841019110021]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-10

Devices Manufactured by Klein Surgical Systems, Inc.

• 10850048763644 - Klein Surgical: 2024-01-19 Klein Sterilization Tray
• 30850048763808 - Klein Surgical: 2023-09-08 Disposable Monopolar Endoscopic Cord 10 ft. (3.0m)
• 10850048763194 - Klein Surgical: 2023-07-25 Klein Bulldog Clamp 45mm Straight
• 10850048763200 - Klein Surgical: 2023-07-25 Klein Bulldog Clamp 60mm Straight
• 10850048763217 - Klein Surgical: 2023-07-25 Klein Bulldog Clamp 17mm Straight
• 10850048763224 - Klein Surgical: 2023-07-25 Klein Bulldog Clamp 25mm Straight
• 10850048763231 - Klein Surgical: 2023-07-25 Klein Bulldog Clamp 35mm Straight
• 10850048763248 - Klein Surgical: 2023-07-25 Klein Bulldog Clamp 17mm Curved