FDA.report

E&Q Master / Gun needle set [23G]

Primary DI
08806387890331
Brand
E&Q Master / Gun needle set [23G]
Company
Meta Biomed Co., Ltd.
Model
9033
Device description
Warmed Gutta Percha Obturation System
Published
2022-09-24
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
false

Related Records

Product Codes

CodeName
EKRPlugger, Root Canal, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08806387890331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08806387890331088063878903318806387890331

GMDN Terms

TermDefinition
Endodontic obturation systemAn assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688322841
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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08806387814788MG 02-15 LM14782025-08-26
08806387814795MG 02-20 LM14792025-08-26

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