FDA.reportPublic FDA data

Lumindex 3 LED Transilluminator Barrier Sleeves

Primary DI
00723896011164
Brand
Lumindex 3 LED Transilluminator Barrier Sleeves
Company
PRACTICON, INC.
Model
7118837
Catalog number
71-18837
Device description
cover light tip and Lumindex 3 handpiece to prevent cross-contamination.
Published
2018-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00723896011164PrimaryGS10
00723896009079Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00723896011164007238960111647238960111640723896011164
00723896009079007238960090797238960090790723896009079

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, non-sterileA non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119193803
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00723896029855Practicon Color Splash™ Saliva Ejectors 100/Pack715824771582472026-01-08
00723896029886Practicon Bliss™ Level 3 Face Mask 50/Box Black7158246 BLA7158246 BLA2026-01-08
00723896029916Practicon Bliss™ Level 3 Face Mask 50/Box Blue7158246 BLU7158246 BLU2026-01-08
00723896030295ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack715824971582492026-01-08
00723896030325ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/Pack715825071582502026-01-08
00723896030356ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/Pack715825171582512026-01-08
00723896030387ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/Pack715825271582522026-01-08
00723896030417ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/Pack715825371582532026-01-08
00723896030448ECOsply™ Biodegradable Disposable Impression Trays Small Lower 10/Pack715825471582542026-01-08
00723896030479ECOsply™ Biodegradable Disposable Impression Trays Quadrant UR/LL 10/Pack715825571582552026-01-08
00723896030509ECOsply™ Biodegradable Disposable Impression Trays Quadrant UL/LR 10/Pack715825671582562026-01-08
00723896030530ECOsply™ Biodegradable Disposable Impression Trays Anterior Upper 10/Pack715825771582572026-01-08
00723896030561ECOsply™ Biodegradable Disposable Impression Trays Anterior Lower 10/Pack715825871582582026-01-08
00723896030592ECOsply™ Biodegradable Disposable Impression Trays Assortment 10/Pack715825971582592026-01-08
00723896025321TTL Easy Size 2.5X Loupes Red7131117 RED7131117 RED2026-01-07
00723896025338TTL Easy Size 3.0X Loupes Red7131118 RED7131118 RED2026-01-07
00723896025505TTL Easy Size 2.5X Loupes Silver7131117 SIL7131117 SIL2026-01-07
00723896025512TTL Easy Size 3.0X Loupes Silver7131118 SIL7131118 SIL2026-01-07
00723896029558Practicon® Standard 2x2 Non-Woven Sponges 200/Pack715823871582382026-01-07
00723896029589Practicon® Premium 2x2 Non-Woven Sponges 200/Pack715824071582402026-01-07

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00840456215074JMUJMU DENTAL, INCEIF2025-07-15
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