AccessGUDID - DEVICE: Pindex (D661PX1480)

GUDID

Device Identifier (DI) Information

Brand Name: Pindex
Version or Model: PX148
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COLTENE/WHALEDENT INC

Primary DI Number: D661PX1480
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622185718 *Terms of Use

Device Description: 2 Flexible Molds

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?
45420	Dental laboratory power tool system	An assembly of devices intended to be used in a dental laboratory to bore/cut/grind dental fixtures, appliances, and materials for their preparation or repair. It typically consists of a drilling handpiece, a compact mains electricity (AC-powered) motor, an enclosed and flexible spinning cable (e.g., a Bowden cable), and a variety of dental power tool attachments to hold the active instruments (e.g., drills, burs, grind wheels). The spinning cable provides power to the handpiece from the electric motor which is placed distant from the site of operation, providing additional protection from exposure to electrical current. The system is typically combined with various speed controllers.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, Implant, Dental, Endosseous

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: f7c57e31-bd3e-4680-b2ca-f42dfb6ccebb
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 26, 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
No Package DIs found

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: 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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