FDA.report

Bull Frog "Expert" Series S.E.

Primary DI
00014081111302
Brand
Bull Frog "Expert" Series S.E.
Company
HAGER WORLDWIDE, INC.
Model
B11130
Device description
dental saliva ejector (low volume) valve, stainless steel
Published
2023-03-28
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
EHZEvacuator, oral cavity

Product Code Classifications

CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00014081111302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00014081111302000140811113020140811113020014081111302

GMDN Terms

TermDefinition
Dental delivery system irrigation handpieceA hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable 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
true
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
true

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00723896029855Practicon Color Splash™ Saliva Ejectors 100/PackPRACTICON, INC.EHZ2026-01-08
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