AccessGUDID - DEVICE: PDT, Inc. (00813677021182)

GUDID

Device Identifier (DI) Information

Brand Name: PDT, Inc.
Version or Model: R194 Probe 11 (3-6-8-11)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R194
Company Name: PDT, INC.

Primary DI Number: 00813677021182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 125850144 *Terms of Use

Device Description: R194 - The PDT 11 Probe is a single-end probe with markings at 3-6-8-11mm coupled with a mobility probe.

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?
35812	Dental surgical probe, reusable	A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIX	Probe, Periodontic

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 84306b98-fb9f-40e5-8eeb-29a226225152
Public Version Date: July 25, 2025
Public Version Number: 3
DI Record Publish Date: April 30, 2021