FDA.reportPublic FDA data

Fiber Optic Light Wand

Primary DI
00842102111792
Brand
Fiber Optic Light Wand
Company
FLEXBAR MACHINE CORPORATION
Model
72076-Mini
Device description
Flex-Light Fiber Optic Light Kit (for Mini-Bookler Systems)
Published
2019-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FDGRetractor, Fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDGRetractor, FiberopticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842102111792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102111792008421021117928421021117920842102111792

GMDN Terms#

Term, Definition table
TermDefinition
Operating lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
047644935
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842102116421Bookler Table Mounted Retractor Systems72072-42026-03-19
00842102116391Bookler Table Mounted Retractor Systems757072026-02-09
00842102116407Bookler Table Mounted Retractor Systems69615-102026-02-09
00842102116384StrongArm Surgical Holders and Positioners212812025-11-26
00842102116377Bookler Table Mounted Retractor Systems750662025-09-12
00842102116360Flexarm Surgical Holders and Positioners75-99056-QC-BS012025-08-26
00842102116339Mini-Bookler Table Mounted Retractor Systems551002025-08-18
00842102116346Mini-Bookler Table Mounted Retractor Systems55100-SA2025-08-18
00842102116353Mini-Bookler Table Mounted Retractor Systems550182025-08-18
00842102116322Mediflex Universal Round Bar Table Mounted Retractor Systems75843-R2025-08-06
00842102116315Holders and Positioners - Nathanson Hooks758442025-07-28
00842102116254Mini-Bookler Table Mounted Retractor Systems55013-IL2025-07-11
00842102116261Mini-Bookler Table Mounted Retractor Systems55014-IL2025-07-11
00842102116278Mini-Bookler Table Mounted Retractor Systems55015-IL2025-07-11
00842102116285Mini-Bookler Table Mounted Retractor Systems55016-IL2025-07-11
00842102116292Mini-Bookler Table Mounted Retractor Systems55017-IL2025-07-11
00842102116308Mini-Bookler Table Mounted Retractor Systems55018-IL2025-07-11
00842102116247StrongArm Surgical Holders and Positioners73001-SA-LP2025-05-05
00842102116230Flexarm Surgical Holders and Positioners38048-22025-04-29
00842102116193Bookler Table Mounted Retractor Systems758142025-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812432023218Lumitex Surgical Tube IlluminatorLumitex, Inc.FDG2026-03-23
G4255721131S0My MedicalMy Medical Store LLCFDG2026-02-27
00812432023133Light Cable, Vaginal RetractorLumitex, Inc.FDG2026-02-11
00812432023164Medtronic 4mm Universal Reusable Light CableLUMITEX, INC.FDG2026-01-07
00812432023171Medtronic 4mm ACMI Cable AdapterLUMITEX, INC.FDG2026-01-07
00812432023188Medtronic 4mm WOLF Cable AdapterLUMITEX, INC.FDG2026-01-07
00812432023195Medtronic 4mm OLYMPUS Cable AdapterLUMITEX, INC.FDG2026-01-07
00812432023201Medtronic 4mm STORZ Cable AdapterLUMITEX, INC.FDG2026-01-07
03662663273350Timberline Lateral Fusion SystemHighridge Medical, LLCFDG2025-12-18
00812432023072L&K Biomed BluEX Surgical IlluminatorLUMITEX, INC.FDG2025-12-11
00812432023096Lumitex Surgical IlluminatorLumitex, Inc.FDG2025-10-23
008124320230654WEB Medical OA51S Surgical IlluminatorLUMITEX, INC.FDG2025-04-08
00840183529512BR Surgical, LLCBR Surgical, LLCFDG2025-02-12
00812432023041Precision Spine TLIF Bifurcated Surgical IlluminatorLUMITEX, INC.FDG2024-10-25
00812432023058Lattus Spine Surgical IlluminatorLUMITEX, INC.FDG2024-06-21
00840183514235BR Surgical, LLCBR Surgical, LLCFDG2024-03-11
G4251106670My MedicalMy Medical Store LLCFDG2024-03-07
G425110679LS0My MedicalMy Medical Store LLCFDG2024-03-07
00840183525620BR Surgical, LLCBR Surgical, LLCFDG2024-03-04
10888515319360BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319414BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319421BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319438BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
00888515319455BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
00888515319462BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319476BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-20
00190376508085ATEC Light Cable SystemALPHATEC SPINE, INC.FDG2024-02-02
00190376508092ATEC Light Cable SystemALPHATEC SPINE, INC.FDG2024-02-02
00840183513887BR Surgical, LLCBR Surgical, LLCFDG2024-02-01
00840306811586Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FDG2024-01-30