AccessGUDID - DEVICE: Nu Alloy Caps. Jar X 50

GUDID

Device Identifier (DI) Information

Brand Name: Nu Alloy Caps. Jar X 50 - 2 Spill
Version or Model: 86910
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 86910
Company Name: PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A

Primary DI Number: 07701126651000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 880141023 *Terms of Use

Device Description: Nu Alloy Caps. Jar X 50 - 2 Spill

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?
34836	Dental amalgam alloy	A composite of metals in fine particles, consisting mainly of silver (Ag), tin (Sn) and small amounts of copper (Cu), that is intended for mixing with mercury (Hg) to produce dental amalgam. Amalgam is a dental restorative material used to fill tooth cavities. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OIV	Dental Amalgam
ELY	Mercury
EJJ	Alloy, Amalgam

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140125	000

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: 6c038b3d-19a6-4b72-a30c-63d3b189c948
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 24, 2017