FDA.reportPublic FDA data

Eikon LT Adapt Smoke Evacuation

Primary DI
00816728021599
Brand
Eikon LT Adapt Smoke Evacuation
Company
INVUITY, INC.
Model
135mm Retractor
Catalog number
A135SE
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816728021599Direct MarkingGS10
00816728021414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816728021599008167280215998167280215990816728021599
00816728021414008167280214148167280214140816728021414

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic retractor handleA 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
TypeValueUnit
Length135Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+0118002533210inst.stryker.cs@stryker.com
+1(866)624-4422xx@xx.xx

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 DIBrandModelCatalogPublished
00816728020165Synthes Fiber Optic CableSingle115001, 03.809.7332016-09-22
00816728020172Synthes Fiber Optic CableBifurcated115002, 03.809.7342016-09-22
00816728020189Invuity® Fiber Optic CableSingle1100002016-09-22
00816728020219Invuity® Fiber Optic CableBifurcated1100012016-09-22
00816728020233Eikon Sterilization TrayNarrowST1B2016-09-22
00816728020264Invuity® Sterilization TraySmall1102002016-09-22
00816728020271Invuity® Fiber Optic Sterilization TrayLarge1102102016-09-22
00816728020288Invuity® Steam Sterilization Tray1.5 x 6 x 10 in110702016-09-22
00816728020295Invuity® Steam Sterilization Tray1.5 x 10 x 15 in111852016-09-22
00816728020301Breiten Sterilization TrayNarrow109642016-09-22
00816728020318Breiten Sterilization TrayStandard109652016-09-22
00816728020455PhotonSaber YFin TipES2Y2016-09-22
00816728020639PhotonBlade™PB1PB12019-06-03
00816728020653PhotonGuideWide / Angled1025212019-06-03
00816728021575Eikon LT Adapt Smoke Evacuation90mm RetractorA90SE2019-08-09
00816728021582Eikon LT Adapt Smoke Evacuation90mm, Teeth RetractorA90TSE2019-08-09
00816728021124Eikon LT Adapt Smoke Evacuation90mm, Wide, RetractorA90WSE2019-10-07
00816728021131Eikon LT Adapt Smoke Evacuation90mm, Wide, Teeth RetractorA90WTSE2019-10-07
00816728021605Eikon LT Adapt Smoke Evacuation135mm, Teeth RetractorA135TSE2019-08-09
00816728021162Eikon LT Adapt Smoke Evacuation135mm, Wide RetractorA135WSE2019-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190471NAPACIFIC INSTRUMENTS, INC.GAD2026-07-09
00888937033663ONETRAC™Coopersurgical, Inc.GAD2026-07-09
00888937033670ONETRAC™Coopersurgical, Inc.GAD2026-07-09
00841536148473ThompsonThompson Surgical Instruments, Inc.GAD2026-07-08
00850083275341Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275570Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275969Intrace USAPILOTIS TECH LLCGAD2026-07-03
B8035202680ORTHOMEDORTHO-MED, INC.GAD2026-06-26
00190776421748MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421809MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421816MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421830MillenniumAvalign Technologies, Inc.GAD2026-06-24
00192896123540Green RetractorSONTEC INSTRUMENTS, INC.GAD2026-06-24
00810220800447Adler Instrument CompanyAdler, Inc.GAD2026-06-24
00190776421649MillenniumAvalign Technologies, Inc.GAD2026-06-23
00190776421670MillenniumAvalign Technologies, Inc.GAD2026-06-23
00810158211292PRINCETONPrinceton Medical Group, Inc.GAD2026-06-23
00348783011456Premier Sawyer RetractorPREMIER DENTAL PRODUCTS COMPANYGAD2026-06-10
00348783011463Premier Sawyer RetractorPREMIER DENTAL PRODUCTS COMPANYGAD2026-06-10
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008401944956603P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956843P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
05060212055323Silicone Bands 2.16mm x 110mm dia x 3DTR MEDICAL LIMITEDGAD2026-06-10
00198506091339ELMED INCORPORATEDELMED INCORPORATEDGAD2026-06-09
00840277133670Innomed, Inc.INNOMED, INC.GAD2026-06-09
04049047155324GimmiGimmi GmbHGAD2026-06-08
G453PM1580030BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-06-08
00846159040524SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040531SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04