FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515319462
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
OM1242
Catalog number
OM1242
Device description
MIS Ortholight - Malleable (5 Per Box)
Published
2024-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00888515319462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515319462008885153194628885153194620888515319462

GMDN Terms#

Term, Definition table
TermDefinition
Open surgical site internal lightAn electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(540)832-5000orders@bossinstruments.com

Regulatory Flags#

DUNS number
848522678
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00888515149311BOSS Instruments90-7060P90-7060P2024-12-11
00888515231184BOSS Instruments90-700590-70052024-12-11
00888515231191BOSS Instruments90-700790-70072024-12-11
00888515231207BOSS Instruments90-700990-70092024-12-11
00888515231214BOSS Instruments90-701190-70112024-12-11
00888515231221BOSS Instruments90-701390-70132024-12-11
00888515231238BOSS Instruments90-702090-70202024-12-11
00888515231245BOSS Instruments90-702290-70222024-12-11
00888515231252BOSS Instruments90-702490-70242024-12-11
00888515231269BOSS Instruments90-702690-70262024-12-11
00888515231276BOSS Instruments90-702890-70282024-12-11
00888515231283BOSS Instruments90-703990-70392024-12-11
00888515231290BOSS Instruments90-7039P90-7039P2024-12-11
00888515231306BOSS Instruments90-704090-70402024-12-11
00888515231320BOSS Instruments90-7040P90-7040P2024-12-11
00888515231337BOSS Instruments90-704290-70422024-12-11
00888515231351BOSS Instruments90-7042P90-7042P2024-12-11
00888515231368BOSS Instruments90-704490-70442024-12-11
00888515231382BOSS Instruments90-7044P90-7044P2024-12-11
00888515231399BOSS Instruments90-704690-70462024-12-11

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
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
00840306811623Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FDG2024-01-30