AccessGUDID - DEVICE: Ena Post (EMICCPF10071)

GUDID

Device Identifier (DI) Information

Brand Name: Ena Post
Version or Model: CPF1007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CPF1007
Company Name: MICERIUM SPA

Primary DI Number: EMICCPF10071
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 436661136 *Terms of Use

Device Description: Ena Post ENAPOST Fiber Post Conicity 10%

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:	Yes
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?
35868	Dental restoration retention pin	A device intended to be placed permanently in the tooth to provide retention and/or stabilization for a dental restoration (e.g., a filling or a crown). It is typically made of stainless steel or titanium (Ti) and comes in a variety of sizes (e.g., 1.0 mm to 3.2 mm). The device is inserted into a pre-drilled hole in the tooth and is secured by threading, friction and/or cementing.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
EJL	Bur, Dental

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: 1.8 Millimeter
Outer Diameter: 0.7 Millimeter

Device Record Status

Public Device Record Key: 177c4a3a-034f-44c4-8261-af3a8ba69ed7
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: EMICCPF10070 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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