Catalog Number

-

Brand Name

DORA

Version/Model Number

BAIN-A.V.F-007SG

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"

-

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

FIE

Product Code Name

Needle, Fistula

Public Device Record Key

0bf0bfd9-6b91-4e9b-9cf0-5f3d4d6b876b

Public Version Date

June 14, 2021

Public Version Number

2

DI Record Publish Date

November 15, 2019

Package DI Number

26948082700655

Quantity per Package

10

Contains DI Package

16948082700658

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-