FDA.report

Health-Tec/DHP Saliva Ejectors

Primary DI
D773540HT100PP31
Brand
Health-Tec/DHP Saliva Ejectors
Company
Dental Health Products Inc
Model
540-HT100PP3
Catalog number
540-HT100PP3
Device description
Health-Tec/DHP Saliva Ejectors Pink with Pink Tip 100/bag
Published
2022-09-27
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

Product Codes

CodeName
DYNMouthpiece, Saliva Ejector

Product Code Classifications

CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D773540HT100PP31PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental suction system cannula, single-useA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
623191194
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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