Seeker-Fulcrum - Seeker Fulcrum - Left - TREACE MEDICAL CONCEPTS, INC.

Duns Number:054808082

Device Description: Seeker Fulcrum - Left

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More Product Details

Catalog Number

-

Brand Name

Seeker-Fulcrum

Version/Model Number

1405-2480

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

-

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

8ceba16a-30ba-45eb-9af1-97310420bd4f

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TREACE MEDICAL CONCEPTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 158
2 A medical device with a moderate to high risk that requires special controls. 25