AccessGUDID - DEVICE: Ena Post (EMICCS0504R1)

GUDID

Device Identifier (DI) Information

Brand Name: Ena Post
Version or Model: CS050-4R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CS050-4R
Company Name: MICERIUM SPA

Primary DI Number: EMICCS0504R1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 436661136 *Terms of Use

Device Description: Enamel Plus Shiny Ricambi - Diamond strips

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):	No
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?
63358	Dental abrasive strip, reusable	A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHM	Strip, Polishing Agent

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 120 Millimeter
Height: 2.0 Millimeter

Device Record Status

Public Device Record Key: f60e2d5e-b50c-4fe3-b1f3-46c6b64f7ca9
Public Version Date: May 11, 2023
Public Version Number: 1
DI Record Publish Date: May 03, 2023

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: EMICCS0504R0 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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