FDA.reportPublic FDA data

LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)

Primary DI
00853277008091
Brand
LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)
Company
UVISION 360, INC.
Model
LUMBx-360 DOWN
Catalog number
20085
Device description
LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)
Published
2021-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid
FCKInstrument, Biopsy, Suction
HFFAspirator, Endometrial
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FCKInstrument, Biopsy, SuctionGastroenterology, Urology2
HFFAspirator, EndometrialObstetrics/Gynecology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210512000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210512000LUMINELLE DTx SystemUvision360, Inc.2021-06-30FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853277008098PackageGS15In Commercial Distribution
20853277008095PackageGS130In Commercial Distribution
00853277008091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085327700809810853277008098
2085327700809520853277008095
00853277008091008532770080918532770080910853277008091

GMDN Terms#

Term, Definition table
TermDefinition
Endometrial biopsy curetteA hand-held, surgical instrument used to for the removal of small amounts of endometrial secretions and/or tissue from the uterus for biopsy purposes. It is typically made of high-grade stainless steel and is available in a variety of designs: 1) a long, thin, instrument with very small spoon-like scoop terminating at either end and a centrally placed handle; 2) a long, thin tubular device with a serrated opening at the distal end and a connection to a suction device or a syringe at the proximal end; or 3) a single-ended device with a scraper at the distal end. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Fahrenheit60 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
080826327
Device count
1
Lot or batch
true
Expiration 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
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
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