FDA.reportPublic FDA data

Endiscope and accessories

Primary DI
00846338002879
Brand
Endiscope and accessories
Company
ELLIQUENCE, LLC
Model
11-2417
Device description
Dia: 3.0mm, Length: 310mm
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZOChisel, Surgical, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846338002879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846338002879008463380028798463380028790846338002879

GMDN Terms#

Term, Definition table
TermDefinition
Spinal endoscopic-access systemAn assembly of devices used to gain access to the spine by dilation of the overlying tissues for the placement and support of an endoscope. It typically includes the endoscope, a light source, a fibreoptic light cable, a camera control unit, a camera, and cannulae (portals). It is used for posterior or anterior access and visualization of a surgical area of the cervical, thoracic, or lumbar spine, allowing the surgeon to perform a procedure such as, a discectomy, nucleotomy, spinal fusion, spinal decompression, foraminotomy, or insertion of spinal implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
019872358
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846338001209IEC BiPolar Cable, DisposableIEC-DJX/12026-06-03
00846338001230Bipolar CableBCD-EU/12026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsBCD-FP/12026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsIEC-JX/B2026-06-03
00846338001582IEC Power Cord 110vIEC-PC1102026-06-03
00846338001605IEC Power Cord 220v ANZ PlugIEC-PCANZ2026-06-03
00846338001612IEC Power Cord 220v EuropeIEC-PCEU2026-06-03
00846338001629IEC Power Cord U.K. 220vIEC-PCUK2026-06-03
00846338005436Working Port15-29062026-06-02
00846338005689Curette15-25372026-06-02
00846338005696Curette15-25382026-06-02
00846338005702Curette15-25392026-06-02
00846338005719Forceps15-16312026-06-02
00846338005726Forceps15-16322026-06-02
00846338005757Forceps15-16432026-06-02
00846338005764Forceps15-16442026-06-02
00846338005771Forceps15-16512026-06-02
00846338005788Forceps15-16522026-06-02
00846338005801Kerrison15-19252026-06-02
00846338005818Kerrison15-19262026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800068960467BENCOXCorentec Co., LtdFZO2026-06-09
08806373887697BENCOX Surgical InstrumentsCorentec Co., LtdFZO2026-04-10
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10649111095245Sklar®SKLAR CORPORATIONFZO2018-09-27
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10603295084020SIGMADEPUY (IRELAND)FZO2018-09-24
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10381780499176Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18
10381780499183Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18