FDA.reportPublic FDA data

Isolation Gown

Primary DI
00076914950069
Brand
Isolation Gown
Company
Petoskey Plastics, Inc.
Model
FG-P9950-06A
Device description
Non-Sterile isolation gown.
Published
2024-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Gown

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00076914950069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00076914950069000769149500690769149500690076914950069

GMDN Terms#

Term, Definition table
TermDefinition
Professional examination gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
231-347-2602mkeiswetter@petoskeyplastics.com

Regulatory Flags#

DUNS number
969231617
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040179205Dental Chair Slip n Grip Gusseted CoverFG-H1174-022024-03-15
10304040179212Dental Chair Slip n Grip Gusseted CoverFG-H1174-072024-03-15
10304040179229Dental Chair Slip n Grip Gusseted CoverFG-H1174-032024-03-15
10304040179236Dental Chair Slip n Grip Gusseted CoverFG-H1174-042024-03-15
10304040179243Dental Chair Slip n Grip Gusseted CoverFG-H1174-052024-03-15
10304040179250Dental Chair Slip n Grip Gusseted CoverFG-H1174-062024-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
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10197106779781CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
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10197106829097CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106818862CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-05
10197106820759CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-29
10197106741979CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-11
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10197106796115CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106743669CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26
10197106744192CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26