FDA.report

Quinelato

Primary DI
07898506843473
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QD.220.02
Catalog number
QD.220.02
Device description
Paiva plugger n° 2
Published
2022-11-29
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
EKGCondenser, Amalgam And Foil, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07898506843473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07898506843473078985068434737898506843473

GMDN Terms

TermDefinition
Endodontic pluggerA hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
899060826
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
true

Other Devices From This Company

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07899798207509QuinelatoQD.721.15QD.721.152024-04-15
07899798207530QuinelatoQD.724.25QD.724.252024-04-15
07899798207547QuinelatoQD.725.30QD.725.302024-04-15
07899798207585QuinelatoQB.301.01QB.301.012024-04-15
07899798207592QuinelatoQB.302.01QB.302.012024-04-15
07899798207608QuinelatoQB.302.02QB.302.022024-04-15
07899798207615QuinelatoQB.301.02QB.301.022024-04-15
07899798207622QuinelatoQB.301.03QB.301.032024-04-15

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