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

• 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