PDT, Inc. - Probe WHO-UNC15 - PDT, INC.

Duns Number:125850144

Device Description: Probe WHO-UNC15

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More Product Details

Catalog Number

200

Brand Name

PDT, Inc.

Version/Model Number

R200 Probe WHO-UNC15

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EIX

Product Code Name

Probe, Periodontic

Device Record Status

Public Device Record Key

83ce8562-3673-4e37-a733-906e32beca5c

Public Version Date

May 17, 2022

Public Version Number

2

DI Record Publish Date

April 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PDT, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 248