T-Lok™ Bone Marrow Tray - T-Lok™ Bone Marrow Tray without Lidocaine - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: T-Lok™ Bone Marrow Tray without Lidocaine

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More Product Details

Catalog Number

BMT1104TLLF

Brand Name

T-Lok™ Bone Marrow Tray

Version/Model Number

BMT1104TLLF

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"

Yes

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

KNW

Product Code Name

Instrument, Biopsy

Device Record Status

Public Device Record Key

c43f3978-c3a2-4c03-a2da-870dda7d0df5

Public Version Date

May 25, 2018

Public Version Number

1

DI Record Publish Date

April 24, 2018

Additional Identifiers

Package DI Number

20886333224146

Quantity per Package

5

Contains DI Package

00886333224142

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