FDA.reportPublic FDA data

Uvision Hysteroscope

Primary DI
00853277008015
Brand
Uvision Hysteroscope
Company
UVISION 360, INC.
Model
LUMDTx-A1
Catalog number
20010
Published
2019-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181909000Luminelle DTx Hysteroscopy SystemUvision360, Inc.2018-08-16FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853277008015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853277008015008532770080158532770080150853277008015

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.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
080826327
Device count
1
Serial number
true
Manufacturing date on label
true
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
00853277008022Uvision Hysteroscope Cable200502019-05-30
00853277008039Luminelle DTx Control Hub200122019-05-30
00853277008046LUMINELLE DTx Hysteroscopy SystemLumDTX-A200302019-05-30
10853277008050LUMINELLE DTx 360 Rigid Rotatable Disposable SheathLUMDTx-360R200602019-06-17
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
07613327055306NASTRYKER CORPORATIONFAJ2016-09-23
07613327055313NASTRYKER CORPORATIONHIH2016-09-23
07613327055313NASTRYKER CORPORATIONFAJ2016-09-23
07613327055320NASTRYKER CORPORATIONFAJ2016-09-23
07613327055337NASTRYKER CORPORATIONFAJ2016-09-23
07613327055344NASTRYKER CORPORATIONFAJ2016-09-23
07613327055351NASTRYKER CORPORATIONFAJ2016-09-23
07613327055368NASTRYKER CORPORATIONFAJ2016-09-23
07613327055375NASTRYKER CORPORATIONFAJ2016-09-23
07613327055382NASTRYKER CORPORATIONFAJ2016-09-23
07613327055399NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONFAJ2016-09-23
07613327055405NASTRYKER CORPORATIONFAJ2016-09-23
07613327055405NASTRYKER CORPORATIONHIH2016-09-23
07613327055412NASTRYKER CORPORATIONFAJ2016-09-23
07613327055429NASTRYKER CORPORATIONFAJ2016-09-23
07613327055436NASTRYKER CORPORATIONFAJ2016-09-23
07613327055443NASTRYKER CORPORATIONFAJ2016-09-23
07613327055450NASTRYKER CORPORATIONFAJ2016-09-23
07613327055467NASTRYKER CORPORATIONFAJ2016-09-23
07613327055474NASTRYKER CORPORATIONFAJ2016-09-23
07613327055481NASTRYKER CORPORATIONFAJ2016-09-23
07613327055498NASTRYKER CORPORATIONHIH2016-09-23
07613327055498NASTRYKER CORPORATIONFAJ2016-09-23
07613327055504NASTRYKER CORPORATIONFAJ2016-09-23
07613327055511NASTRYKER CORPORATIONFAJ2016-09-23
07613327055528NASTRYKER CORPORATIONFAJ2016-09-23
07613327055535NASTRYKER CORPORATIONFAJ2016-09-23
07613327055542Rev360STRYKER CORPORATIONFAJ2016-09-23
07613327055542Rev360STRYKER CORPORATIONHIH2016-09-23