LORcup - X-HALTATION LIMITED

Duns Number:748679816

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More Product Details

Catalog Number

-

Brand Name

LORcup

Version/Model Number

Large

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"

-

For Single-Use

-

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

HHE

Product Code Name

Cup, Menstrual

Device Record Status

Public Device Record Key

4af08281-275e-45c7-b99c-5b860440dde8

Public Version Date

January 28, 2021

Public Version Number

1

DI Record Publish Date

January 20, 2021

Additional Identifiers

Package DI Number

09421906547054

Quantity per Package

168

Contains DI Package

09421906547030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"X-HALTATION LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2