Eikon LT Adapt Smoke Evacuation A175TSE

GUDID 00816728021643

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.

STRYKER CORPORATION

Fibreoptic retractor handle
Primary Device ID00816728021643
NIH Device Record Keycb63dad9-60ed-45c2-87ec-3ba1f170fdda
Commercial Distribution StatusIn Commercial Distribution
Brand NameEikon LT Adapt Smoke Evacuation
Version Model NumberA175TSE
Catalog NumberA175TSE
Company DUNS187502109
Company NameSTRYKER CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx

Device Dimensions

Length175 Millimeter
Device Size Text, specify0
Length175 Millimeter
Device Size Text, specify0
Length175 Millimeter
Device Size Text, specify0
Length175 Millimeter
Device Size Text, specify0
Length175 Millimeter
Device Size Text, specify0
Length175 Millimeter
Device Size Text, specify0
Length175 Millimeter
Device Size Text, specify0
Length175 Millimeter
Device Size Text, specify0
Length175 Millimeter
Device Size Text, specify0
Length175 Millimeter
Device Size Text, specify0
Length175 Millimeter
Device Size Text, specify0
Length175 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100816728021506 [Primary]
GS100816728021643 [Direct Marking]

FDA Product Code

GADRetractor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816728021643]

Moist Heat or Steam Sterilization


[00816728021643]

Moist Heat or Steam Sterilization


[00816728021643]

Moist Heat or Steam Sterilization


[00816728021643]

Moist Heat or Steam Sterilization


[00816728021643]

Moist Heat or Steam Sterilization


[00816728021643]

Moist Heat or Steam Sterilization


[00816728021643]

Moist Heat or Steam Sterilization


[00816728021643]

Moist Heat or Steam Sterilization


[00816728021643]

Moist Heat or Steam Sterilization


[00816728021643]

Moist Heat or Steam Sterilization


[00816728021643]

Moist Heat or Steam Sterilization


[00816728021643]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2025-08-20
Device Publish Date2019-08-09

On-Brand Devices [Eikon LT Adapt Smoke Evacuation]

00816728021445LT Adapt Smoke Evacuation Retractor, 135mm, Wide, Teeth
00816728021513LT Adapt Smoke Evacuation Retractor, 175mm, Wide
00816728021384LT Adapt Smoke Evacuation Retractor, 90mm, Teeth
00816728021643Intended to provide tissue retraction and surgical site illumination from a high intensity light

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