Catalog Number

001-101S

Brand Name

General Instruments

Version/Model Number

001-101S

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

-

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

ECP

Product Code Name

INSTRUMENT, LIGATURE TUCKING, ORTHODONTIC

Public Device Record Key

b524c6e8-3448-4052-81e8-75ecf9089408

Public Version Date

August 20, 2020

Public Version Number

1

DI Record Publish Date

August 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-