AccessGUDID - DEVICE: Ref-Line (EPOLREFN3C10)

GUDID

Device Identifier (DI) Information

Brand Name: Ref-Line
Version or Model: REF.N3C1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: REF.N3C1
Company Name: POLIDENT d.o.o.

Primary DI Number: EPOLREFN3C10
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 644778409 *Terms of Use

Device Description: REFN3C1

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):	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?
38643	Resin artificial teeth	Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.	Active	false

[?]

FDA Product Code

Product Code	Product Code Name
ELM	Denture, Plastic, Teeth

[?]

FDA Premarket Submission

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

Sterilization

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

Storage and Handling
No storage/handling found

[?]

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

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

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

Customer Contact

[?]

DEVICE: Ref-Line (EPOLREFN3C10)

Device Identifier (DI) Information

Device Characteristics

GMDN

FDA Product Code

FDA Premarket Submission

Sterilization

Storage and Handling

Clinically Relevant Size

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI

Secondary DI

Unit of Use DI

Direct Marking (DM)

Production Identifier(s) in UDI

Customer Contact