Synthes Fiber Optic Cable 115001, 03.809.733

GUDID 00816728020165

Intended to provide surgical site illumination from a high intensity light source.

INVUITY, INC.

Fibreoptic light cable
Primary Device ID00816728020165
NIH Device Record Key9a6885ee-67fe-4c23-ae0d-ff7dcbff7794
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynthes Fiber Optic Cable
Version Model NumberSingle
Catalog Number115001, 03.809.733
Company DUNS175697908
Company NameINVUITY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8667117768
Emailcustomerservice@invuity.com
Phone8667117768
Emailcustomerservice@invuity.com
Phone8667117768
Emailcustomerservice@invuity.com

Device Dimensions

Length8 Feet
Length8 Feet
Length8 Feet

Device Identifiers

Device Issuing AgencyDevice ID
GS100816728020165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FSTLight, Surgical, Fiberoptic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816728020165]

Moist Heat or Steam Sterilization


[00816728020165]

Moist Heat or Steam Sterilization


[00816728020165]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-24
Device Publish Date2016-09-22

On-Brand Devices [Synthes Fiber Optic Cable]

00816728020172Intended to provide surgical site illumination from a high intensity light source.
00816728020165Intended to provide surgical site illumination from a high intensity light source.

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