FDA.reportPublic FDA data

Eikon LT Adapt Smoke Evacuation

Primary DI
00816728021445
Brand
Eikon LT Adapt Smoke Evacuation
Company
STRYKER CORPORATION
Model
A135WTSE
Catalog number
A135WTSE
Device description
LT Adapt Smoke Evacuation Retractor, 135mm, Wide, Teeth
Published
2019-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00816728021179Direct MarkingGS10
00816728021445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816728021179008167280211798167280211790816728021179
00816728021445008167280214458167280214450816728021445

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
Device Size Text, specify0
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
187502109
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
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07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24

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Primary DI, Brand, Company table
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