FDA.reportPublic FDA data

Dental Chair Slip n Grip Gusseted Cover

Primary DI
10304040179205
Brand
Dental Chair Slip n Grip Gusseted Cover
Company
Petoskey Plastics, Inc.
Model
FG-H1174-02
Device description
Dental Chair Cover non sterile
Published
2024-03-15
Public version status
Update
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
NRUChair, Dental, Without Operative Unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040179205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1030404017920510304040179205

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length27Inch
Width24Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-231-347-2602mkeiswetter@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
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
00076914950069Isolation GownFG-P9950-06A2024-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971119541323Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2026-03-30
00841709121845MidmarkMIDMARK CORPORATIONNRU2026-03-18
00841336111288Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336108554Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336110199Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-09-28
10194665008383A-decA-DEC, INC.NRU2025-09-18
D178A12H0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
D178A6E0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
06971119541316Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119541880Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119542375Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
10194665006587A-decA-DEC, INC.NRU2025-05-19
10194665006594A-decA-DEC, INC.NRU2025-05-19
08800266944368Luvis Chair (LC700C-chair only plus)DENTIS CO. ,LTDNRU2025-02-21
10194665007911A-decA-DEC, INC.NRU2025-01-24
D1355370DOME Innovation ChairDome, Inc.NRU2025-01-14
TQ26126151051Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
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TQ26126151881Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
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TQ26126151080Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151740Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151880Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
D06037062730DentalezDentalez Alabama, Inc.NRU2024-11-05
D0603706273PT0DentalezDentalez Alabama, Inc.NRU2024-11-05