Catalog Number

BAN-11SF

Brand Name

BAN-11SF, F/G, STERILE

Version/Model Number

11 Gauge x 13cm

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

b97ae9dc-b799-4816-81cc-35145fccf0ca

Public Version Date

November 25, 2019

Public Version Number

1

DI Record Publish Date

November 15, 2019

Package DI Number

20857878007440

Quantity per Package

10

Contains DI Package

10857878007443

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case