Synthes Fiber Optic Cable

Primary DI
00816728020165
Brand
Synthes Fiber Optic Cable
Company
INVUITY, INC.
Model
Single
Catalog number
115001, 03.809.733
Device description
Intended to provide surgical site illumination from a high intensity light source.
Published
2016-09-22
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
FSTLight, Surgical, Fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090070000INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEMInvuity, Inc.2009-04-22FST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816728020165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816728020165008167280201658167280201650816728020165

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Feet

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8667117768customerservice@invuity.com

Regulatory Flags#

DUNS number
175697908
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00816728021599Eikon LT Adapt Smoke Evacuation135mm RetractorA135SE2019-08-09
00816728021605Eikon LT Adapt Smoke Evacuation135mm, Teeth RetractorA135TSE2019-08-09
00816728021162Eikon LT Adapt Smoke Evacuation135mm, Wide RetractorA135WSE2019-10-07

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