Hex Cortical Screw 2.7mm - Hex Cortical Screw 2.7, 27mm - TRIMED, INCORPORATED

Duns Number:138041277

Device Description: Hex Cortical Screw 2.7, 27mm

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More Product Details

Catalog Number

HEX2.7-27

Brand Name

Hex Cortical Screw 2.7mm

Version/Model Number

HEX2.7-27

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K060041

Product Code Details

Product Code

HWC

Product Code Name

Screw, fixation, bone

Device Record Status

Public Device Record Key

85f5a8e9-48e0-47e4-8265-9a8e8e156112

Public Version Date

January 19, 2021

Public Version Number

1

DI Record Publish Date

January 11, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRIMED, INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 555
2 A medical device with a moderate to high risk that requires special controls. 1934