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
00763000703929MSB CAPSTONE CONTROL™ Spinal System39914222026-08-27
00763000703936MSB CAPSTONE CONTROL™ Spinal System39914272026-08-27
00763000703950MSB CAPSTONE CONTROL™ Spinal System39915222026-08-27
00763000703967MSB CAPSTONE CONTROL™ Spinal System39915272026-08-27
00763000703981MSB CAPSTONE CONTROL™ Spinal System39916222026-08-27
00763000703998MSB CAPSTONE CONTROL™ Spinal System39916272026-08-27
00763000704001MSB CAPSTONE CONTROL™ Spinal System39916322026-08-27
00763000704018MSB CAPSTONE CONTROL™ Spinal System39917222026-08-27
00763000704025MSB CAPSTONE CONTROL™ Spinal System39917272026-08-27
00763000704032MSB CAPSTONE CONTROL™ Spinal System39917322026-08-27
00763000704049MSB CAPSTONE CONTROL™ Spinal System39913322026-08-27
00763000704063MSB CAPSTONE CONTROL™ Spinal System39908272026-08-27
00763000704070MSB CAPSTONE CONTROL™ Spinal System39909222026-08-27
00763000704100MSB CAPSTONE CONTROL™ Spinal System39910272026-08-27
00763000704117MSB CAPSTONE CONTROL™ Spinal System39910322026-08-27
00763000704124MSB CAPSTONE CONTROL™ Spinal System39911222026-08-27
00763000704131MSB CAPSTONE CONTROL™ Spinal System39911272026-08-27
00763000704148MSB CAPSTONE CONTROL™ Spinal System39911322026-08-27
00763000704155MSB CAPSTONE CONTROL™ Spinal System39912222026-08-27
00763000704162MSB CAPSTONE CONTROL™ Spinal System39912272026-08-27

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