FDA.report

Dental Chair Slip n Grip Gusseted Cover

Primary DI
10304040179243
Brand
Dental Chair Slip n Grip Gusseted Cover
Company
Petoskey Plastics, Inc.
Model
FG-H1174-05
Device description
Dental chair 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

Related Records

Contact Domains

Product Codes

CodeName
NRUChair, Dental, Without Operative Unit

Product Code Classifications

CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040179243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1030404017924310304040179243

GMDN Terms

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

TypeValueUnit
Length48Inch
Width56Inch

Sterilization Methods

Method

Contacts

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 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
10304040179229Dental Chair Slip n Grip Gusseted CoverFG-H1174-032024-03-15
10304040179236Dental Chair Slip n Grip Gusseted CoverFG-H1174-042024-03-15
10304040179250Dental Chair Slip n Grip Gusseted CoverFG-H1174-062024-03-15

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