FDA.reportPublic FDA data

LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath

Primary DI
10853277008050
Brand
LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath
Company
UVISION 360, INC.
Model
LUMDTx-360R
Catalog number
20060
Published
2019-06-17
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
false

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190827000Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidUvision360, Inc.2019-06-06HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853277008050PackageGS15In Commercial Distribution
00853277008053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085327700805010853277008050
00853277008053008532770080538532770080530853277008053

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, single-useA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
080826327
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853277008107LUMINELLE AspiratorLUM-A200812024-02-29
10853277008104LUMINELLE AspiratorLUM-A200812024-02-29
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)LUMBx-360 UP200802021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)LUMBx-360 DOWN200852021-08-13
10853277008081LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)LUMBx-360 UP200802021-08-13
10853277008098LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)LUMBx-360 DOWN200852021-08-13
00853277008060LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic)LUMDx-360200702019-11-07
00853277008053LUMINELLE DTx 360 Rigid Rotatable Disposable SheathLUMDTx-360R200602019-06-17
00853277008008LUMINELLE DTx 360 Rotatable Disposable SheathsLUMDTx-360200202019-05-30
00853277008015Uvision HysteroscopeLUMDTx-A1200102019-05-30
00853277008022Uvision Hysteroscope Cable200502019-05-30
00853277008039Luminelle DTx Control Hub200122019-05-30
00853277008046LUMINELLE DTx Hysteroscopy SystemLumDTX-A200302019-05-30
10853227708054LUMINELLE DTx 360 Rigid Rotatable Disposable SheathLUMDTx-360R200602019-06-17
00853227708002LUMINELLE DTx 360 Rotatable Disposable SheathsLUMDTx-360200202019-05-30
00853227708019Uvision HysteroscopeLUMDTx-A1200102019-05-30
00853227708026Uvision Hysteroscope Cable200502019-05-30
00853227708033Luminelle DTx Control Hub200122019-05-30
00853227708040LUMINELLE DTx Hysteroscopy SystemLumDTX-A200302019-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840432200001CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00840432200018CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00810116023424Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAJ2026-05-06
00850023925381AptraOtu Medical Inc.FAJ2024-09-30
00850023925398AptraOtu Medical Inc.FAJ2024-09-30
00850023925428WiScope®Otu Medical Inc.FAJ2024-09-30
00850023925435WiScope®Otu Medical Inc.FAJ2024-09-30
04055207038512RIWORichard Wolf GmbHFAJ2024-08-19
04055207008607NARichard Wolf GmbHFAJ2024-08-19
00677964074936ENDO SMARTCAPMEDIVATORS INC.FAJ2024-05-29
07613327616675SPYSTRYKER CORPORATIONFAJ2024-02-27
07613327616736SPYSTRYKER CORPORATIONFAJ2024-02-27
10818634025149AmbuBosma EnterprisesFAJ2023-05-01
10818634025194AmbuBosma EnterprisesFAJ2023-05-01
50724995219241ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219258ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219265ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219272ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
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00848657076159AED Flexible Cystoscopy Alligator Forcep D/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076166AED Flexible Cystoscopy Rat Tooth Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00860008483706Uro-G Flexible CystoscopeUROVIU CORP.FAJ2022-12-16
00850006759668Aveta Auto 5 Fr Disposable Resecting DeviceMEDITRINA, INC.FAJ2022-08-18
00850023925169WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925176WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925183WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925190WiScope®Otu Medical Inc.FAJ2022-04-18
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13