FDA.report

Morelli

Primary DI
07895742002749
Brand
Morelli
Company
Dental Morelli Ltda
Model
75.01.007
Catalog number
75.01.007
Device description
Band Marker 5.0 - 4.5 - 4.0 - 3.5 mm
Published
2021-05-15
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

Contact Domains

Product Codes

CodeName
ECRSETTER, BAND, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECRSetter, Band, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07895742002749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07895742002749078957420027497895742002749

GMDN Terms

TermDefinition
Orthodontic elastomeric appliance pusherA hand-held device intended to be used by laypersons to remove/apply orthodontic elastomeric appliances (e.g., inter-arch bands, inter-bracket chains) from/to orthodontic brackets. It is typically a thin plastic device with a hook on one end and a pusher on the other, intended to be used by a patient in the home (e.g., before and after eating or sleep). This is a single-use device.

Sterilization Methods

Method
Dry Heat Sterilization

Contacts

PhoneEmail
+551532388226sac@morelli.com.br

Regulatory Flags

DUNS number
907156371
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
true
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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07895742290146Morelli37.20.01837.20.0182025-12-01
07895742290153Morelli37.20.01937.20.0192025-12-01
07895742292218Morelli65.05.11165.05.1112025-09-23
07895742292232Morelli65.05.11265.05.1122025-09-23
07895742289096Morelli30.40.05030.40.0502025-05-28
07895742289102Morelli30.40.05130.40.0512025-05-28
07895742245542Morelli75.01.15275.01.1522025-04-08
07895742245559Morelli75.01.15375.01.1532025-04-08
07895742245566Morelli75.01.15475.01.1542025-04-08
07895742288501Morelli37.10.21037.10.2102025-02-11
07895742288570Morelli37.10.60337.10.6032025-02-11
07895742274023Morelli10.15.72310.15.7232024-12-09
07895742274030Morelli10.15.72510.15.7252024-12-09
07895742286729Morelli20.13.90020.13.9002024-12-06
07895742289904Morelli30.06.30430.06.3042024-09-27
07895742275297Morelli30.06.30330.06.3032024-09-24
07895742285982Morelli50.14.90250.14.9022024-09-23
07895742289348Morelli37.20.00337.20.0032024-09-09
07895742289355Morelli37.20.01737.20.0172024-09-09
07895742285999Morelli50.14.90050.14.9002024-09-02

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