Tentacle

GUDID 04545499071194

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 Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use Hand-held surgical retractor, single-use

• Primary Device ID: 04545499071194
• NIH Device Record Key: 4ad059d7-4066-4d9c-af89-e738066e5aba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tentacle
• Version Model Number: MD-27310
• 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	04545499071194 [Primary]
GS1	24545499071198 [Package]; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-03
• Device Publish Date: 2020-05-26

Devices Manufactured by SUMITOMO BAKELITE COMPANY LIMITED

• 24545499071693 - Tentacles NEO: 2021-04-12 This Product is intended to stabilize the position and the direction of the heart by attaching it to the surface of the heart du
• 04545499071194 - Tentacle: 2020-06-03This 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.
• 04545499071194 - Tentacle: 2020-06-03 This Product is intended to stabilize the position and the direction of the heart by attaching it to the surface of the heart du
• 24545499070832 - Tentacles NEO: 2019-11-25 This Product is intended to stabilize the position and the direction of the heart by attaching it to the surface of the heart du
• 24545499064664 - SB Knife™: 2019-11-04 The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This d
• 24545499064671 - SB Knife™: 2019-11-04 The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This d
• 24545499064688 - SB Knife™: 2019-11-04 The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This d
• 24545499064695 - SB Knife™: 2019-11-04 The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This d
• 04545499070098 - Flexible Overtube: 2019-10-01 Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for end