FDA.reportPublic FDA data

Working Tube - Sealing Cap

Primary DI
00846338002565
Brand
Working Tube - Sealing Cap
Company
ELLIQUENCE, LLC
Model
11-2922
Published
2025-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846338002565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846338002565008463380025658463380025650846338002565

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
Manufacturing date on label
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
B382SD9176201020Surgical DirectSurgical Direct, Inc.MDM2026-07-13
03661219436348LANDANGERLANDANGERMDM2026-07-12
00810158210615PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00810158215917PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713015PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713039PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713046PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713053PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
03661219436522LANDANGERLANDANGERMDM2026-07-08
03661219436584LANDANGERLANDANGERMDM2026-07-08
03661219436706LANDANGERLANDANGERMDM2026-07-08
04054462915583evonosevonos GmbH & Co. KGMDM2026-06-25
00198506091612ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00198506091629ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00810158211179PRINCETONPrinceton Medical Group, Inc.MDM2026-06-23
00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091407ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091209ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-03
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
00846338007126Endiscope and accessoriesELLIQUENCE, LLCMDM2026-06-02
00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
B356KE392100American MedicalsAmerican MedicalsMDM2026-05-29
B356KE396100American MedicalsAmerican MedicalsMDM2026-05-29
08717903490617Humeca MAX Carrier 1:1 Humeca B.V.MDM2026-03-31