FDA.report

Health-Tec/DHP Air/Water Syringe Tips

Primary DI
D773540HT150W1
Brand
Health-Tec/DHP Air/Water Syringe Tips
Company
Dental Health Products Inc
Model
540-HT150W
Catalog number
540-HT150W
Device description
Health-Tec/DHP Air/Water Syringe Tips White Metal Core 150/bag
Published
2022-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ECBUnit, Syringe, Air And/Or Water

Product Code Classifications

CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D773540HT150W1PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental delivery system irrigation handpiece tipA rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. 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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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