5.0mm Pin Guide Multi-Pin Clamp - ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Duns Number:117858154

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More Product Details

Catalog Number

-

Brand Name

5.0mm Pin Guide Multi-Pin Clamp

Version/Model Number

0366

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 22, 2018

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

60dd4d00-458a-4768-906d-bffd12a57a52

Public Version Date

June 24, 2020

Public Version Number

5

DI Record Publish Date

January 22, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED ORTHOPAEDIC SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 542
2 A medical device with a moderate to high risk that requires special controls. 2485