Catalog Number

-

Brand Name

Deltec

Version/Model Number

21-2027-24

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

K830730,K830730

Product Code

LGT

Product Code Name

STIMULATOR, SPINAL-CORD, IMPLANTED FOR MOTOR DISORDERS

Public Device Record Key

7ad4f47b-370a-4fd1-aad6-2cf426c306da

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

September 01, 2015

Package DI Number

30610586028469

Quantity per Package

12

Contains DI Package

00610586028468

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX