Tantalum Bead Set - Tantalum bead implants are used as radio-opaque - Halifax Biomedical Incorporated

Duns Number:241237150

Device Description: Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue

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More Product Details

Catalog Number

P005603

Brand Name

Tantalum Bead Set

Version/Model Number

2

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

NEU

Product Code Name

Marker, Radiographic, Implantable

Device Record Status

Public Device Record Key

b4ecc89d-c2c4-4c84-a77d-0dec7ced06a4

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 22, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HALIFAX BIOMEDICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2