HNM SPORTS MEDICINE - ETHOS BUTTON CL, 30mm LOOP, (2) #5 SUTURE - HNM STAINLESS, LLC.

Duns Number:806754185

Device Description: ETHOS BUTTON CL, 30mm LOOP, (2) #5 SUTURE

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More Product Details

Catalog Number

HNM-OBCL-TI-30

Brand Name

HNM SPORTS MEDICINE

Version/Model Number

HNM-OBCL-TI-30

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

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

-

Product Code Details

Product Code

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Device Record Status

Public Device Record Key

93781247-ff65-43c1-8c17-f64885b1ecc0

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

August 16, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HNM STAINLESS, LLC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 729