Large LumenEye x1 Manifold -30mm

Primary DI
05060768280750
Brand
Large LumenEye x1 Manifold -30mm
Company
SURGEASE INNOVATIONS LIMITED
Model
LX1-LMB-301
Catalog number
LX1-LMB-301
Device description
Large Manifold to be used with LumenEye X1
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FANSigmoidoscope, Rigid, Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FANSigmoidoscope, Rigid, ElectricalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232262000LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )Surgease Innovations Limited2023-11-30FAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060768280767PackageGS125In Commercial Distribution
05060768280750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060768280767050607682807675060768280767
05060768280750050607682807505060768280750

Regulatory Flags#

DUNS number
221628713
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060768280040Consumable Pack (Sheath, Obturator, Manifold & Camera Cover)LX1-CCS-202LX1-CCS-2022026-05-13
05060768280231Consumable Pack (Sheath, Obturator & Manifold)LX1-CSB-201LX1-CSB-2012026-05-13
05060768280286LumenEye X1 ScopeLX1-SCP-203LX1-SCP-2032026-05-13
05060768280736Large LumenEye x1 Manifold -26mm LX1-LMB-261LX1-LMB-2612026-05-13
05060768280576SESISSIS-CSB-1012026-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060768280040Consumable Pack (Sheath, Obturator, Manifold & Camera Cover)SURGEASE INNOVATIONS LIMITEDFAN2026-05-13
05060768280231Consumable Pack (Sheath, Obturator & Manifold)SURGEASE INNOVATIONS LIMITEDFAN2026-05-13
05060768280286LumenEye X1 ScopeSURGEASE INNOVATIONS LIMITEDFAN2026-05-13
05060768280736Large LumenEye x1 Manifold -26mm SURGEASE INNOVATIONS LIMITEDFAN2026-05-13