Tentacles NEO

GUDID 24545499071693

This Product is intended to stabilize the position and the direction of the heart by attaching it to the surface of the heart during Off-Pump CABG for deployment of field of view.

SUMITOMO BAKELITE COMPANY LIMITED

Hand-held surgical retractor, single-use

• Primary Device ID: 24545499071693
• NIH Device Record Key: a4fd790b-4c64-4fde-87f0-34fc92b692eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tentacles NEO
• Version Model Number: MD-27320A
• Company DUNS: 690551106
• Company Name: SUMITOMO BAKELITE COMPANY LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04545499071699 [Primary]
GS1	24545499071693 [Package]; Contains: 04545499071699; Package: Box [1 Units]; In Commercial Distribution

FDA Product Code

• MWS: Stabilizer, Heart

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-04-12
• Device Publish Date: 2019-11-15

On-Brand Devices [Tentacles NEO]

• 24545499070832: This Product is intended to stabilize the position and the direction of the heart by attaching i
• 24545499071693: This Product is intended to stabilize the position and the direction of the heart by attaching i