AccessGUDID - DEVICE: Morelli (07895742002664)

GUDID

Device Identifier (DI) Information

Brand Name: Morelli
Version or Model: 75.01.001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 75.01.001
Company Name: Dental Morelli Ltda

Primary DI Number: 07895742002664
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 907156371 *Terms of Use

Device Description: Elastic Ligature Applicator/Extractor - Plastic

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44861	Orthodontic appliance force gauge	A hand-held dental instrument intended to be used in orthodontics to accurately measure forces (in grams or ounces) applied by the elastics or springs used when setting up orthodontic appliances within the patient's mouth. The device is typically of cylindrical or tubular design (but can be dial-shaped with circular read out) and is made of metal (some partly plastic); it contains a spring-loaded mechanism which indicates the force exerted to pull the appliance elastic or spring to the desired length. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECP	INSTRUMENT, LIGATURE TUCKING, ORTHODONTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 20863c80-85a2-4a49-98de-1bd4c23d25a2
Public Version Date: May 24, 2021
Public Version Number: 1
DI Record Publish Date: May 15, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +551532388226
Email: sac@morelli.com.br

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