FDA.report

VACUUM TIP HVE-SS 6" (ONE VENTED END & ONE NON-VENTED END)

Primary DI
D248B101020
Brand
VACUUM TIP HVE-SS 6" (ONE VENTED END & ONE NON-VENTED END)
Company
HAGER WORLDWIDE, INC.
Model
B10102
Device description
Dental evacuation tip
Published
2023-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DYNMouthpiece, saliva ejector
ECBUNIT, SYRINGE, AIR AND/OR WATER

Product Code Classifications

CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D248B101020PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(828)624-3319d.pritchard@hagerworldwide.com

Regulatory Flags

DUNS number
009277971
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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