FDA.reportPublic FDA data

Endiscope

Primary DI
00846338007164
Brand
Endiscope
Company
ELLIQUENCE, LLC
Model
11-2930
Device description
Blue Sealing Cap no hole
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846338007164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846338007164008463380071648463380071640846338007164

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
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
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
04580826926044PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926051PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926341PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926471PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926488PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926648PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926679PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926686PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926761PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826927232PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826928369PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826928376PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931789PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931796PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931802PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
00810929045668Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045675Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045682Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045699Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045705Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045712Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045729Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045736Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
01081092904567Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045665Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045689Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045696Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045702Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045719Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045726Olympus Endoscopy KitRuhof CorporationMNL2026-08-07