FDA.report

Endo Activator

Primary DI
D716EAPB1001
Brand
Endo Activator
Company
TULSA DENTAL PRODUCTS LLC
Model
EAPB100
Catalog number
EAPB100
Device description
EndoActivator Protective Barr
Published
2022-09-09
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
true

Related Records

Product Codes

CodeName
JETPICK, MASSAGING

Product Code Classifications

CodeDeviceSpecialtyClass
JETPick, MassagingDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D716EAPB1001PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental syringe needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
942778564
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

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D716PUENDO11ProUltraPUENDO1PUENDO12016-10-07
D716PUENDO151ProUltraPUENDO1-5PUENDO1-52016-11-11
D716PUENDO21ProUltraPUENDO2PUENDO22016-10-07
D716PUENDO31ProUltraPUENDO3PUENDO32016-10-07
D716PUENDO41ProUltraPUENDO4PUENDO42016-10-07
D716PUENDO51ProUltraPUENDO5PUENDO52016-10-07
D716PUENDO61ProUltraPUENDO6PUENDO62016-10-07
D716PUENDO681ProUltraPUENDO6-8PUENDO6-82016-11-11
D716PUENDO71ProUltraPUENDO7PUENDO72016-10-07
D716PUENDO81ProUltraPUENDO8PUENDO82016-10-07
D716PUSINE11ProUltraPUSINE1PUSINE12016-10-07
D716PUSINE161ProUltra SINEPUSINE1-6PUSINE1-62016-11-11
D716PUSINE21ProUltraPUSINE2PUSINE22016-10-07
D716PUSINE31ProUltra SINEPUSINE3PUSINE32016-10-07
D716PUSINE41ProUltra SINEPUSINE4PUSINE42016-10-07
D716PUSINE51ProUltra SINEPUSINE5PUSINE52016-10-07
D716PUSINE61ProUltra SINEPUSINE6PUSINE62016-10-07
D716PUSURG11ProUltraPUSURG1PUSURG12016-10-07
D716PUSURG161ProUltraPUSURG1-6PUSURG1-62016-11-11
D716PUSURG21ProUltraPUSURG2PUSURG22016-10-07

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