BIPOLAR CORD REUSABLE K 8-7065

GUDID 00841668112120

KATENA PRODUCTS, INC.

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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