FDA.reportPublic FDA data

Prometheus System Surgical Instrument

Primary DI
08806390891837
Brand
Prometheus System Surgical Instrument
Company
Jeil Medical Corporation
Model
PRO-90025
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GAHStylet, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAHStylet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806390891837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806390891837088063908918378806390891837

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811603
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800089423880Surgical Instrument111-0212026-04-09
08800089458875Leforte MMF System20-MS-0062026-04-09
08800089458882Leforte MMF System20-MS-0082026-04-09
08800089458899Leforte MMF System20-MS-0102026-04-09
08800089458905Leforte MMF System20-MS-0122026-04-09
08800089458912Leforte MMF System20L-MP-L132026-04-09
08800089458929Leforte MMF System20L-MP-U132026-04-09
08800089458936Leforte MMF System20L-MS-0062026-04-09
08800089458943Leforte MMF System20L-MS-0082026-04-09
08800089458950Leforte MMF System20L-MS-0102026-04-09
08800089458967Leforte MMF System20L-MS-0122026-04-09
08800089458974Leforte MMF System20L-MS-F062026-04-09
08800089458981Leforte MMF System20L-MS-F082026-04-09
08800089458998Leforte MMF System20L-MS-F102026-04-09
08800089459001Leforte MMF System20L-MS-F122026-04-09
08800089466801Surgical Instrument112-1942026-04-09
08800089476886Surgical Instrument111-5912026-04-09
08800089476893Surgical Instrument111-6362026-04-09
08806390880350ARIX Rib System Bone Plate24-CVRB-0042022-12-06
08806390880367ARIX Rib System Bone Plate24-CVRB-0062022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663192873Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192897Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192903Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192910Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192927Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
00873263009314Visualase Neuro AccessoriesFHC, INC.GAH2025-12-12
00873263009338Visualase MR Stiffening StyletFHC, INC.GAH2025-12-12
03662663131414Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131506Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131513Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131520Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131537Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
08809204330522LIONHans Biomed Corp.GAH2025-11-26
08809204330539LIONHans Biomed Corp.GAH2025-11-26
08809204330546LIONHans Biomed Corp.GAH2025-11-26
08809204330553LIONHans Biomed Corp.GAH2025-11-26
08809204330560LIONHans Biomed Corp.GAH2025-11-26
08809204330577LIONHans Biomed Corp.GAH2025-11-26
08809204330584LIONHans Biomed Corp.GAH2025-11-26
08809204330591LIONHans Biomed Corp.GAH2025-11-26
08809204330607LIONHans Biomed Corp.GAH2025-11-26
08809204330614LIONHans Biomed Corp.GAH2025-11-26
08809204330621LIONHans Biomed Corp.GAH2025-11-26
08809204330638LIONHans Biomed Corp.GAH2025-11-26
08809204330645LIONHans Biomed Corp.GAH2025-11-26
08809204330652LIONHans Biomed Corp.GAH2025-11-26
08809779585853LIONHans Biomed Corp.GAH2025-11-26
08809779585877LIONHans Biomed Corp.GAH2025-11-26
08809204330515LIONHans Biomed Corp.GAH2025-11-18
00873263009062Visualase Neuro AccessoriesFHC, INC.GAH2025-03-10