TWINFIX - TWINFIX ULTRA 5.5 MM - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: TWINFIX ULTRA 5.5 MM HIDROXYAPATITE ANCHOR WITH TWO No. TWINFIX ULTRA 5.5 MM HIDROXYAPATITE ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE

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More Product Details

Catalog Number

72202626

Brand Name

TWINFIX

Version/Model Number

72202626

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

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

K151105

Product Code Details

Product Code

MBI

Product Code Name

FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Device Record Status

Public Device Record Key

48dc64fc-49d0-49f8-ab2a-a9a940457429

Public Version Date

October 22, 2020

Public Version Number

7

DI Record Publish Date

September 21, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMITH & NEPHEW, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10651
2 A medical device with a moderate to high risk that requires special controls. 35590
3 A medical device with high risk that requires premarket approval 351