AccessGUDID - DEVICE: Mixing Wells (D701MW42)

GUDID

Device Identifier (DI) Information

Brand Name: Mixing Wells
Version or Model: MW-4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PULPDENT CORPORATION

Primary DI Number: D701MW42
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 420
Labeler D-U-N-S® Number*: 001006089 *Terms of Use

Device Description: Disposable. 4-well configuration (420/box)

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?
44999	Dental material mixing surface, chairside, single-use	A pad, tray, 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 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 single-use 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: 8d9b6e0c-26ba-4abd-b79f-6a7f916a0ab3
Public Version Date: May 04, 2023
Public Version Number: 2
DI Record Publish Date: September 21, 2021

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: D701MW41 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
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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