Catalog Number

10001-NB

Brand Name

Microport

Version/Model Number

10001-NB

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

eaacda1b-f720-4816-b81e-2e3548da3654

Public Version Date

January 28, 2022

Public Version Number

2

DI Record Publish Date

September 17, 2021

Package DI Number

00850033380361

Quantity per Package

10

Contains DI Package

00850033380354

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE