FDA.reportPublic FDA data

VELscope

Primary DI
07540201000032
Brand
VELscope
Company
LED Dental Inc
Model
VELsheath Vx
Catalog number
5720
Published
2016-09-24
Public version status
Update
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
NXVDiagnostic Light, Soft Tissue Detector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXVDiagnostic Light, Soft Tissue DetectorDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102083000VELSCOPE VXLed Dental, Inc.2010-11-18NXV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540201000039PackageGS1250In Commercial Distribution
27540201000036PackageGS112In Commercial Distribution
07540201000032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754020100003917540201000039
2754020100003627540201000036
07540201000032075402010000327540201000032

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment handle cover, single-use, non-sterileA non-sterile device designed specifically to cover the handle of a piece of medical equipment (e.g., examination/treatment light) to provide a hygienic barrier between the handle and the hand of a healthcare professional. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.

Regulatory Flags#

DUNS number
243167546
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540201000025VELscopeVELcap Vx57102016-09-24
07540201000049VELscopeVELscope Vx Value Bundle-US46622016-09-24
07540201000094VELscopeVELscope Vx Value Bundle-Basic46602016-12-21
07540201000018VELscopeVELscope Vx4200-12016-08-22
27540201000036VELscopeVELsheath Vx57202016-09-24
07540201000063TuxedoSize 16100, 6100A2016-09-24
07540201000070TuxedoSize 26101, 6101A2016-09-24
07540201000216Tuxedo Size 1 Replacement 6100R2019-06-21
07540201000223Tuxedo Size 2 Replacement 6101R2019-06-21
07540201000230Tuxedo Size 1 Replacement (A-Series)6100AR2019-06-21
07540201000247Tuxedo Size 2 Replacement (A-Series)6101AR2019-06-21
00754020100218Tuxedo Size 1 Replacement 6100R2019-06-21
00754020100225Tuxedo Size 2 Replacement 6101R2019-06-21
00754020100232Tuxedo Size 1 Replacement (A-Series)6100AR2019-06-21
00754020100249Tuxedo Size 2 Replacement (A-Series)6101AR2019-06-21
00754020100041VELscopeVELscope Vx Value Bundle-US46622016-09-24
00754020100096VELscopeVELscope Vx Value Bundle-Basic46602016-12-21
00754020100010VELscopeVELscope Vx4200-12016-08-22
00754020100065TuxedoSize 161002016-09-24
00754020100072TuxedoSize 22016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D8136501180ViziLite®DEN-MAT HOLDINGS, LLCNXV2022-09-22
D813PLS10030ViziLite®DEN-MAT HOLDINGS, LLCNXV2022-09-22
D813PLS10050ViziLite®DEN-MAT HOLDINGS, LLCNXV2022-09-22
D813PLS10080ViziLite®DEN-MAT HOLDINGS, LLCNXV2022-09-22
00860179001075FUSION-DOE Light SystemDentlight Inc.NXV2021-08-09
D86911009002AdDentADDENT, INC.NXV2017-06-01
D8691120010AdDentADDENT, INC.NXV2017-06-01
07540201000094VELscopeLED Dental IncNXV2016-12-21
00754020100096VELscopeLED Dental IncNXV2016-12-21
D813PLS10010VIZILITE PRO DEN-MAT HOLDINGS, LLCNXV2016-11-14
08051040582003G.o.c.c.l.e.s.PIERREL SPANXV2016-10-21
08051040582010G.o.c.c.l.e.s. lightPIERREL SPANXV2016-10-21
00370275123163OralIDForward Science Technologies LLCNXV2016-10-03
07540201000025VELscopeLED Dental IncNXV2016-09-24
27540201000036VELscopeLED Dental IncNXV2016-09-24
07540201000049VELscopeLED Dental IncNXV2016-09-24
00754020100041VELscopeLED Dental IncNXV2016-09-24
D8136501010 ViziLite®DEN-MAT HOLDINGS, LLCNXV2016-09-24
D702RT3003900StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-15
D702RT3001050StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003710StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003720StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003860StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003870StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
07540201000018VELscopeLED Dental IncNXV2016-08-22
00754020100010VELscopeLED Dental IncNXV2016-08-22