Catalog Number

BAN1112CDT

Brand Name

BIOPSYBELL

Version/Model Number

BONE ACCESS NEEDLE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

OCJ

Product Code Name

Spinal Channeling Instrument, Vertebroplasty

Public Device Record Key

82538325-60df-4e3a-9e32-3eb0399bb9ce

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Package DI Number

08033860025076

Quantity per Package

5

Contains DI Package

08033860024772

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BLISTER+POUCH