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

Duns Number:140727624

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

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More Product Details

Catalog Number

BMET1104ATLLF

Brand Name

T-Lok™ Economy Bone Marrow Tray

Version/Model Number

BMET1104ATLLF

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

56690fa6-639a-405a-b467-07b34e292aeb

Public Version Date

May 28, 2018

Public Version Number

1

DI Record Publish Date

April 25, 2018

Additional Identifiers

Package DI Number

20886333224160

Quantity per Package

5

Contains DI Package

00886333224166

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