PDT, Inc. - Explorer/Probe 23/UNC-12 - PDT, INC.

Duns Number:125850144

Device Description: Explorer/Probe 23/UNC-12

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More Product Details

Catalog Number

R227

Brand Name

PDT, Inc.

Version/Model Number

R227 Explorer/Probe 23/UNC-12

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

EKB

Product Code Name

Explorer, Operative

Device Record Status

Public Device Record Key

2cd48593-86a7-4da0-9038-b3ad14caf506

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