DELTA XTEND - DELTA XTEND Central Screw Metaglene depth gauge - DEPUY (IRELAND)

Duns Number:989365556

Device Description: DELTA XTEND Central Screw Metaglene depth gauge

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

231770017

Brand Name

DELTA XTEND

Version/Model Number

2317-70-017

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

6b81fe16-4828-4e27-9633-2d5b304aa981

Public Version Date

January 17, 2022

Public Version Number

1

DI Record Publish Date

January 07, 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