N/A - Distractor Shaver size 11mm - Integrity Implants Inc.

Duns Number:080300717

Device Description: Distractor Shaver size 11mm

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More Product Details

Catalog Number

II-1-0512

Brand Name

N/A

Version/Model Number

II-1-0512

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)

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

64a2633b-878c-4d48-8556-631a7ccf1f31

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

February 08, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRITY IMPLANTS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 787
2 A medical device with a moderate to high risk that requires special controls. 1255