FDA.reportPublic FDA data

N/A

Primary DI
00643169857834
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
9560668
Device description
ILLUMIN SYS 9560668 STRGHT-TIP RADIANCE
Published
2018-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSZLight, surgical, carrier

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSZLight, Surgical, CarrierGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169857834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169857834006431698578346431698578340643169857834

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument fibreoptic lightA sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a surgical intervention. It typcially emits cold light only through its tip to eliminate glare, and may have a self-adhesive coating for attachment to the surgical instrument. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00721902298431TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0182015-08-18
00721902298448TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0202015-08-18
00721902298455TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0222015-08-18
00721902298462TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0242015-08-19
00721902298479TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0262015-08-18
00763000704483MSB CAPSTONE CONTROL™ Spinal System40016272026-07-20
00763000879556MSB Reusable Instruments5210-10222026-07-20
00763000992439MSB INFINITY OCT SystemG365PT40262026-07-20
00763000992446MSB INFINITY OCT SystemG365PT40282026-07-20
00763000993092MSB INFINITY OCT SystemG36555352026-07-20
00199150041183N/A593250152026-07-17
00199150072323Medtronic Reusable InstrumentsX66309032026-07-19
00199150074525Medtronic Reusable InstrumentsEX01260082026-07-19
00199150076024Medtronic Reusable InstrumentsEX03260062026-07-17
00199150081875Medtronic Reusable InstrumentsX04260032026-07-19
00643169511651SOVEREIGN™ Spinal System90100020222026-07-19
00643169511675MSB SOVEREIGN™ Spinal System90100020232026-07-19
00643169511682MSB SOVEREIGN™ Spinal System90100020242026-07-19
00643169511705MSB SOVEREIGN™ Spinal System90100020302026-07-17
00643169511712MSB SOVEREIGN™ Spinal System90100020312026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M678TLCSLS0TracLuxSUNOPTIC TECHNOLOGIES LLCFSZ2023-05-29
M678TLC0TRACLUXSUNOPTIC TECHNOLOGIES LLCFSZ2021-11-05
00816728020646PhotonGuideSTRYKER CORPORATIONFSZ2019-06-03
00816728020653PhotonGuideINVUITY, INC.FSZ2019-06-03
00816728021650PhotonGuideSTRYKER CORPORATIONFSZ2019-06-03
00816728020479PhotonGuide AdaptINVUITY, INC.FSZ2019-06-03
00816728021315PhotonGuide AdaptSTRYKER CORPORATIONFSZ2019-04-19
00816728020066PhotonGuideINVUITY, INC.FSZ2016-09-22
00816728020073PhotonGuideSTRYKER CORPORATIONFSZ2016-09-22
00816728020080PhotonGuideSTRYKER CORPORATIONFSZ2016-09-22
00816728020097PhotonGuideINVUITY, INC.FSZ2016-09-22