AccessGUDID - DEVICE: PRO3DURE GR-16 Xray (EPRCD1001401)

GUDID

Device Identifier (DI) Information

Brand Name: PRO3DURE GR-16 Xray
Version or Model: 1kg - white-opaque
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: pro3dure medical GmbH

Primary DI Number: EPRCD1001401
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312947842 *Terms of Use

Device Description: printodent GR-16 Xray

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?
57949	Dental guided surgery reference plate	A non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for implant placement/fixation). It is a plastic plate of a predefined shape and hole configuration for placement of dental guided surgery reference pins to form a link between a chairside cone beam computerized tomography (CBCT) scan and a coordinate system for dental laboratory fabrication of the scan template (used to scan the patient) and then the surgical dental implant template. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYT	Maintainer, Space Preformed, Orthodontic

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
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c471b51-a045-42a2-b9d3-2da8af61e601
Public Version Date: August 25, 2022
Public Version Number: 1
DI Record Publish Date: August 17, 2022

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +4923749200500
Email: info@pro3dure.com

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