Eikon LT Adapt Smoke Evacuation A90TSE

GUDID 00816728021582

Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

INVUITY, INC.

Fibreoptic retractor handle Fibreoptic retractor handle Fibreoptic retractor handle Fibreoptic retractor handle Fibreoptic retractor handle Fibreoptic retractor handle Fibreoptic retractor handle Fibreoptic retractor handle Fibreoptic retractor handle

• Primary Device ID: 00816728021582
• NIH Device Record Key: 8fdf20f6-d0cd-4e9d-a927-be8177143ad9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eikon LT Adapt Smoke Evacuation
• Version Model Number: 90mm, Teeth Retractor
• Catalog Number: A90TSE
• Company DUNS: 175697908
• Company Name: INVUITY, INC.
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com

Device Dimensions

• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816728021384 [Primary]
GS1	00816728021582 [Direct Marking]

FDA Product Code

• GAD: Retractor

Sterilization

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

[00816728021582]

Moist Heat or Steam Sterilization

[00816728021582]

Moist Heat or Steam Sterilization

[00816728021582]

Moist Heat or Steam Sterilization

[00816728021582]

Moist Heat or Steam Sterilization

[00816728021582]

Moist Heat or Steam Sterilization

[00816728021582]

Moist Heat or Steam Sterilization

[00816728021582]

Moist Heat or Steam Sterilization

[00816728021582]

Moist Heat or Steam Sterilization

[00816728021582]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-24
• Device Publish Date: 2019-08-09

On-Brand Devices [Eikon LT Adapt Smoke Evacuation]

• 30816728021569: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 30816728021552: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 30816728021545: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021063: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021254: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021247: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021636: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021216: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021209: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021629: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021612: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021179: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021162: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021605: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021599: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021131: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021124: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021582: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 00816728021575: Intended to provide tissue retraction and surgical site illumination from a high intensity light
• 30816728021538: Intended to provide tissue retraction and surgical site illumination from a high intensity light