FDA.report

QUIKsheath Barriers Air-Water Syringe

Primary DI
00723896009673
Brand
QUIKsheath Barriers Air-Water Syringe
Company
PRACTICON, INC.
Model
70-19720
Catalog number
70-19720
Device description
reduce contamination and cleanup time between patients for only pennies per sheath. Unique pre-punched design pulls over A-W syringes more easily for an effective barrier. Provides visual assurance of aseptic procedures. Measures approximately 8-½" x 2-½".
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
00723896009673PackageGS120In Commercial Distribution
00723896009666PrimaryGS10
00723896000991Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00723896009673007238960096737238960096730723896009673
00723896009666007238960096667238960096660723896009666
00723896000991007238960009917238960009910723896000991

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

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