Bone Marrow Biopsy Tray - Bone Marrow Biopsy Tray Drug Free with 11ga x - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Bone Marrow Biopsy Tray Drug Free with 11ga x 4"(10cm) T-Lok™ Needle and 15ga Aspiration N Bone Marrow Biopsy Tray Drug Free with 11ga x 4"(10cm) T-Lok™ Needle and 15ga Aspiration Needle

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More Product Details

Catalog Number

ABAK4511DF

Brand Name

Bone Marrow Biopsy Tray

Version/Model Number

ABAK4511DF

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

ff86fc6a-8343-4168-b965-a6c47558e177

Public Version Date

July 27, 2022

Public Version Number

1

DI Record Publish Date

July 19, 2022

Additional Identifiers

Package DI Number

20886333220810

Quantity per Package

5

Contains DI Package

00886333220816

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