INHANCE - INHANCE SHOULDER SYSTEM HEAD DISTRACTOR - DEPUY (IRELAND)

Duns Number:989365556

Device Description: INHANCE SHOULDER SYSTEM HEAD DISTRACTOR

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More Product Details

Catalog Number

620101171

Brand Name

INHANCE

Version/Model Number

6201-01-171

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

8cdfab54-279a-4979-945a-59e349b9bfc4

Public Version Date

September 07, 2021

Public Version Number

1

DI Record Publish Date

August 30, 2021

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