Clavicle Plates - Superior Mediolateral Plate, Lt, 8-Hole - TRIMED, INCORPORATED

Duns Number:138041277

Device Description: Superior Mediolateral Plate, Lt, 8-Hole

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More Product Details

Catalog Number

CPSMLTL-8

Brand Name

Clavicle Plates

Version/Model Number

CPSMLTL-8

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

K112509

Product Code Details

Product Code

HRS

Product Code Name

Plate, fixation, bone

Device Record Status

Public Device Record Key

49374bf9-09b8-49a9-8cc3-b4ce068c780b

Public Version Date

March 03, 2022

Public Version Number

1

DI Record Publish Date

February 23, 2022

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