MediBrief Longer Torso - MediBrief Longer Torso Seamless Knit Pant - Size - MEDI-TECH INTERNATIONAL CORPORATION

Duns Number:063865158

Device Description: MediBrief Longer Torso Seamless Knit Pant - Size SM/MED 2EA/BG, 50BG/CS

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More Product Details

Catalog Number

MBLT22002

Brand Name

MediBrief Longer Torso

Version/Model Number

MBLT22002

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

EYQ

Product Code Name

Garment, Protective, For Incontinence

Device Record Status

Public Device Record Key

7204003b-8d9c-4e66-842e-a662f91999e7

Public Version Date

July 09, 2019

Public Version Number

1

DI Record Publish Date

July 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDI-TECH INTERNATIONAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 226
2 A medical device with a moderate to high risk that requires special controls. 1