PickUp - DISPOSABLE BONE MARROW BIOPSY NEEDLE WITH - M.D.L. S.R.L.

Duns Number:447228586

Device Description: DISPOSABLE BONE MARROW BIOPSY NEEDLE WITH EXTRACTION WIRE,SAFETY, EXTERNAL TRAP-SYSTEM, 11 DISPOSABLE BONE MARROW BIOPSY NEEDLE WITH EXTRACTION WIRE,SAFETY, EXTERNAL TRAP-SYSTEM, 11G X 100 mm

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More Product Details

Catalog Number

PJT1110

Brand Name

PickUp

Version/Model Number

PJT1110

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

DWO

Product Code Name

Needle, Biopsy, Cardiovascular

Device Record Status

Public Device Record Key

80092938-fedd-4b12-af7c-bc82be1b1f17

Public Version Date

May 27, 2021

Public Version Number

2

DI Record Publish Date

May 14, 2021

Additional Identifiers

Package DI Number

18056138586052

Quantity per Package

10

Contains DI Package

08056138586055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"M.D.L. S.R.L." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 228
2 A medical device with a moderate to high risk that requires special controls. 138