FDA.report

QUIKsheath Barriers Low-Speed Straight

Primary DI
00723896009697
Brand
QUIKsheath Barriers Low-Speed Straight
Company
PRACTICON, INC.
Model
70-19721
Catalog number
70-19721
Device description
educe contamination and cleanup time between patients for only pennies per sheath. Unique pre-punched design pulls over handpieces more easily for an effective barrier. Provides visual assurance of aseptic procedures. Measures approximately 9" x 1-½".
Published
2018-07-12
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

Related Records

Product Codes

CodeName
NRDUnit, Operative Dental, Accessories
PEMDental Barriers And Sleeves

Product Code Classifications

CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00723896009697PackageGS120In Commercial Distribution
00723896009680PrimaryGS10
00723896003190Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00723896009697007238960096977238960096970723896009697
00723896009680007238960096807238960096800723896009680
00723896003190007238960031907238960031900723896003190

GMDN Terms

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

Regulatory Flags

DUNS number
119193803
Device count
500
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 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D125100B2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125100C2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251012Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251022Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251032Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125104L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125104S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251062Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251072Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251082Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251092Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251112Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251122Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251132Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251142Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251182Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251192Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123M2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123SS2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123XL2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251252Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125125SS2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251282Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251292Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125133L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125133S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125135L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125135S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22