NA - DEPTH GAUGE - DEPUY (IRELAND)

Duns Number:989365556

Device Description: DEPTH GAUGE

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More Product Details

Catalog Number

481030540

Brand Name

NA

Version/Model Number

4810-30-540

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

HTJ

Product Code Name

GAUGE, DEPTH

Device Record Status

Public Device Record Key

f283cf8f-e9ca-449a-b9de-2bfa0e5c71ac

Public Version Date

February 09, 2022

Public Version Number

1

DI Record Publish Date

February 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEPUY (IRELAND)" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3549
2 A medical device with a moderate to high risk that requires special controls. 2188
3 A medical device with high risk that requires premarket approval 418