AccessGUDID - DEVICE: Premium Plus (D8387470B4)

GUDID

Device Identifier (DI) Information

Brand Name: Premium Plus
Version or Model: 7470-B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Premium Plus International Limited

Primary DI Number: D8387470B4
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 668367758 *Terms of Use

Device Description: MIXING BOWLS

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?
63877	Dental material mixing surface, chairside, reusable	A slab, tray, or well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic or glass and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDZ	Mixer, Cement, For Clinical Use

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
No Device Sizes

Device Record Status

Public Device Record Key: c4f38a22-0880-4f79-a9d6-89240002430a
Public Version Date: May 04, 2023
Public Version Number: 2
DI Record Publish Date: December 27, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
D8387470B8	4	D8387470B6		In Commercial Distribution	CASE
D8387470B6	10	D8387470B4		In Commercial Distribution	BOX

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: 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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