FDA.reportPublic FDA data

Non-Surgical Isolation Gowns

Primary DI
00723896018057
Brand
Non-Surgical Isolation Gowns
Company
PRACTICON, INC.
Model
IL-2030WTU
Catalog number
7146811
Device description
Four layer SMMS fabric isolation gown. Level 2 fluid resistance. Closed front from neck to knees, pullover, tear away neck style. Chest pocket and Thumb-loop cuffs. White. 10 per bag.
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00723896018064PackageGS110In Commercial Distribution
00723896018057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00723896018064007238960180647238960180640723896018064
00723896018057007238960180577238960180570723896018057

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Regulatory Flags#

DUNS number
119193803
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00723896029848Practicon Color Splash™ Saliva Ejectors 100/Pack715824771582472026-01-08
00723896029879Practicon Bliss™ Level 3 Face Mask 50/Box Black7158246 BLA7158246 BLA2026-01-08
00723896029909Practicon Bliss™ Level 3 Face Mask 50/Box Blue7158246 BLU7158246 BLU2026-01-08
00723896030288ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack715824971582492026-01-08
00723896030318ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/Pack715825071582502026-01-08
00723896030349ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/Pack715825171582512026-01-08
00723896030370ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/Pack715825271582522026-01-08
00723896030400ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/Pack715825371582532026-01-08
00723896030431ECOsply™ Biodegradable Disposable Impression Trays Small Lower 10/Pack715825471582542026-01-08
00723896030462ECOsply™ Biodegradable Disposable Impression Trays Quadrant UR/LL 10/Pack715825571582552026-01-08
00723896030493ECOsply™ Biodegradable Disposable Impression Trays Quadrant UL/LR 10/Pack715825671582562026-01-08
00723896030523ECOsply™ Biodegradable Disposable Impression Trays Anterior Upper 10/Pack715825771582572026-01-08
00723896030554ECOsply™ Biodegradable Disposable Impression Trays Anterior Lower 10/Pack715825871582582026-01-08
00723896030585ECOsply™ Biodegradable Disposable Impression Trays Assortment 10/Pack715825971582592026-01-08
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

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