UNI-CLIP - The UNI-CLIP STAPLE is designed so that, by - NEWDEAL

Duns Number:536935331

Device Description: The UNI-CLIP STAPLE is designed so that, by widening the diamond shaped opening, mechanica The UNI-CLIP STAPLE is designed so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled with many choice of sizes (11, 12, 13 or 15mm interaxis, and lengths vary from 13 to 20mm). The UNI-CLIP STAPLE is made from Stainless Steel and it is indicated for fixation of bone fractures or for bone reconstruction. It is delivered sterile.

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More Product Details

Catalog Number

213217SND

Brand Name

UNI-CLIP

Version/Model Number

213217SND

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"

Yes

For Single-Use

Yes

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

K011716,K991482

Product Code Details

Product Code

JDR

Product Code Name

STAPLE, FIXATION, BONE

Device Record Status

Public Device Record Key

5f97bf2b-9feb-4481-83fd-a94901756e05

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

October 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEWDEAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 388
2 A medical device with a moderate to high risk that requires special controls. 235