StarMed Latex Exam Glove - StarMed Latex Exam Glove, size S - SEMPERMED USA, INC.

Duns Number:004072158

Device Description: StarMed Latex Exam Glove, size S

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More Product Details

Catalog Number

SM102

Brand Name

StarMed Latex Exam Glove

Version/Model Number

SM102

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

-

Product Code Details

Product Code

LYY

Product Code Name

Latex Patient Examination Glove

Device Record Status

Public Device Record Key

0cf5b236-a1b7-4cdd-9d73-4d0cadd30839

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

January 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEMPERMED USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 54