Home GUDID 00816728021636 Eikon LT Adapt Smoke Evacuation
Primary DI 00816728021636
Brand Eikon LT Adapt Smoke Evacuation
Company INVUITY, INC.
Model 175mm Retractor
Catalog number A175SE
Device description 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.
Published 2019-08-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GAD Retractor
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAD Retractor General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816728021636 Direct Marking GS1 0 00816728021490 Primary GS1 0 00816728021506 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816728021636 00816728021636 816728021636 0816728021636 00816728021490 00816728021490 816728021490 0816728021490 00816728021506 00816728021506 816728021506 0816728021506
GMDN Terms# Term, Definition table Term Definition Fibreoptic retractor handle A hand-held surgical instrument with an integral fibreoptic bundle intended to accept a retractor blade (not included) to: 1) enable manipulation of the blade during non-self-retaining surgical retraction of tissues; and 2) provide illumination of deep surgical sites typically during abdominal or pelvic surgical procedures. The fibreoptic bundle is attached to a separate light source, typically via a light-source cable, to produce illumination. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Length 90 Millimeter Length 175 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 175697908 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00816728020165 Synthes Fiber Optic Cable Single 115001, 03.809.733 2016-09-22 00816728020172 Synthes Fiber Optic Cable Bifurcated 115002, 03.809.734 2016-09-22 00816728020189 Invuity® Fiber Optic Cable Single 110000 2016-09-22 00816728020219 Invuity® Fiber Optic Cable Bifurcated 110001 2016-09-22 00816728020233 Eikon Sterilization Tray Narrow ST1B 2016-09-22 00816728020264 Invuity® Sterilization Tray Small 110200 2016-09-22 00816728020271 Invuity® Fiber Optic Sterilization Tray Large 110210 2016-09-22 00816728020288 Invuity® Steam Sterilization Tray 1.5 x 6 x 10 in 11070 2016-09-22 00816728020295 Invuity® Steam Sterilization Tray 1.5 x 10 x 15 in 11185 2016-09-22 00816728020301 Breiten Sterilization Tray Narrow 10964 2016-09-22 00816728020318 Breiten Sterilization Tray Standard 10965 2016-09-22 00816728020455 PhotonSaber Y Fin Tip ES2Y 2016-09-22 00816728020639 PhotonBlade™ PB1 PB1 2019-06-03 00816728020653 PhotonGuide Wide / Angled 102521 2019-06-03 00816728021575 Eikon LT Adapt Smoke Evacuation 90mm Retractor A90SE 2019-08-09 00816728021582 Eikon LT Adapt Smoke Evacuation 90mm, Teeth Retractor A90TSE 2019-08-09 00816728021124 Eikon LT Adapt Smoke Evacuation 90mm, Wide, Retractor A90WSE 2019-10-07 00816728021131 Eikon LT Adapt Smoke Evacuation 90mm, Wide, Teeth Retractor A90WTSE 2019-10-07 00816728021599 Eikon LT Adapt Smoke Evacuation 135mm Retractor A135SE 2019-08-09 00816728021605 Eikon LT Adapt Smoke Evacuation 135mm, Teeth Retractor A135TSE 2019-08-09
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