Bone Marrow Biopsy - Custom Bone Marrow Biopsy Tray - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Custom Bone Marrow Biopsy Tray

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More Product Details

Catalog Number

CB0429TLA

Brand Name

Bone Marrow Biopsy

Version/Model Number

CB0429TLA

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

OJT

Product Code Name

Aspiration Tray

Device Record Status

Public Device Record Key

e5df4c88-2ddb-4b63-8e1a-e03588937eff

Public Version Date

July 07, 2022

Public Version Number

1

DI Record Publish Date

June 29, 2022

Additional Identifiers

Package DI Number

20886333225563

Quantity per Package

5

Contains DI Package

00886333225569

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205