FDA.reportPublic FDA data

ORACLE

Primary DI
H98103809925S0
Brand
ORACLE
Company
Synthes GmbH
Model
03.809.925S
Catalog number
03809925S
Device description
ORACLE RETRACTOR LIGHT CLIP- STERILE
Published
2018-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
10705034726724PrimaryGS10
H98103809925S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503472672410705034726724

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic operating light systemA system of lights intended to be used in the operating room (OR) to illuminate the surgical site over a prolonged period for optimal visualization of small, low-contrast objects at varying depths or through small incisions. It operates through light provided by a light source, usually located outside of the surgical field, which is delivered through fibreoptic cables to the site of operation. The cables will be mounted, e.g., from the ceiling or attached to a suitable floor mount, or they may possibly connect directly to the surgeons head-worn head light.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982350435NASD03.100.130SD031001302026-02-11
10886982350442NASD03.100.131SD031001312026-02-11
10886982350459NASD03.100.132SD031001322026-02-11
10886982350466NASD03.100.133SD031001332026-02-11
10886982351579NASD399.190SD3991902026-02-11
10886982351661NASD03.010.001SD030100012026-02-11
10886982351678NASD03.010.002SD030100022026-02-11
10886982361288NASD03.405.001SD034050012026-02-11
10886982361295NASD03.100.038SD031000382026-02-11
10887587078502NASD03.501.443SD035014432026-02-11
10887587078571NASD386.902SD3869022026-02-11
10886982351586NASD03.045.001SD030450012026-02-10
10886982351593NASD03.045.003SD030450032026-02-10
10886982362186NASD03.233.016SD032330162026-01-10
10886982362193NASD03.233.017SD032330172026-01-10
10886982362209NASD03.233.018SD032330182026-01-10
10886982362216NASD03.233.019SD032330192026-01-10
10886982361257VOLT60.529.210605292102025-12-16
H9810460002902S0NA04.600.029.02S0460002902S2019-08-20
H9810460002910S0NA04.600.029.10S0460002910S2019-08-20

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