FDA.reportPublic FDA data

Dental Chair Slip n Grip Gusseted Cover

Primary DI
10304040179229
Brand
Dental Chair Slip n Grip Gusseted Cover
Company
Petoskey Plastics, Inc.
Model
FG-H1174-03
Device description
Dental chair cover non sterile
Published
2024-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10304040179229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1030404017922910304040179229

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00076914950069Isolation GownFG-P9950-06A2024-03-18
10304040179205Dental Chair Slip n Grip Gusseted CoverFG-H1174-022024-03-15
10304040179212Dental Chair Slip n Grip Gusseted CoverFG-H1174-072024-03-15
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
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
TQ26126151050Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151060Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151070Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
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
D0603706273RW0DentalezDentalez Alabama, Inc.NRU2024-11-05
D0603706275PT0DentalezDentalez Alabama, Inc.NRU2024-11-05
10194665007324A-decA-DEC, INC.NRU2024-09-04
00304040186176EssentialsHENRY SCHEIN, INC.NRU2024-08-14
00304040186183EssentialsHENRY SCHEIN, INC.NRU2024-08-14
00810021435855DCI EdgeDCI International, LLCNRU2024-08-02
00810021435862DCI EdgeDCI International, LLCNRU2024-08-02
00810021435961DCI EdgeDCI International, LLCNRU2024-08-02
00810021435978DCI EdgeDCI International, LLCNRU2024-08-02