BIPOLAR CORD REUSABLE K 8-7065

GUDID 00841668112120

KATENA PRODUCTS, INC.

Electrosurgical cable adaptor Electrosurgical cable adaptor Electrosurgical cable adaptor Electrosurgical cable adaptor Electrosurgical cable adaptor Electrosurgical cable adaptor Electrosurgical cable adaptor Electrosurgical cable adaptor Electrosurgical cable adaptor Electrosurgical cable adaptor Electrosurgical cable adaptor Electrosurgical cable adaptor

• Primary Device ID: 00841668112120
• NIH Device Record Key: 46a2d4a6-0f9d-4d34-8a25-45d350e06f27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIPOLAR CORD REUSABLE
• Version Model Number: K 8-7065
• Catalog Number: K 8-7065
• Company DUNS: 085668598
• Company Name: KATENA PRODUCTS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841668112120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942194

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00841668112120]

Ethylene Oxide

[00841668112120]

Ethylene Oxide

[00841668112120]

Ethylene Oxide

[00841668112120]

Ethylene Oxide

[00841668112120]

Ethylene Oxide

[00841668112120]

Ethylene Oxide

[00841668112120]

Ethylene Oxide

[00841668112120]

Ethylene Oxide

[00841668112120]

Ethylene Oxide

[00841668112120]

Ethylene Oxide

[00841668112120]

Ethylene Oxide

[00841668112120]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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