PediNail - PEDINAIL DEPTH GAUGE, 10-100 (PURPLE), - ORTHOPEDIATRICS CORP.

Duns Number:796416191

Device Description: PEDINAIL DEPTH GAUGE, 10-100 (PURPLE),

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More Product Details

Catalog Number

01-1500-0035

Brand Name

PediNail

Version/Model Number

01-1500-0035

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2021

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)

Yes

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

HTJ

Product Code Name

GAUGE, DEPTH

Device Record Status

Public Device Record Key

8dc62ac7-b589-46dd-b1ea-6146e198ac6e

Public Version Date

September 30, 2021

Public Version Number

3

DI Record Publish Date

August 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOPEDIATRICS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1662
2 A medical device with a moderate to high risk that requires special controls. 7273