1st Choice - Box - AMMEX CORPORATION

Duns Number:187070768

Device Description: Box

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More Product Details

Catalog Number

-

Brand Name

1st Choice

Version/Model Number

1ENXL

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

520f87a5-0515-4264-8de7-0acf89645e8a

Public Version Date

October 31, 2022

Public Version Number

2

DI Record Publish Date

July 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMMEX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 106