Catalog Number

-

Brand Name

NA

Version/Model Number

TDLC205

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

Yes

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

-

FDA Premarket Submission

-

Product Code

OGJ

Product Code Name

Nerve Block Tray

Public Device Record Key

628ad4e8-b428-4322-8222-6621780bbab0

Public Version Date

October 08, 2020

Public Version Number

1

DI Record Publish Date

September 30, 2020

Package DI Number

20858965006575

Quantity per Package

10

Contains DI Package

00858965006571

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-