Alleset - Universal Extremity - GRI Medical & Electronic Technology Co., Ltd.

Duns Number:679894738

Device Description: Universal Extremity Drape_90inx124in_Non-sterile_10EA/CS

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More Product Details

Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 83-09101

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

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

PUI

Product Code Name

Drape, surgical, exempt

Device Record Status

Public Device Record Key

235505ab-e65a-4597-a36b-df9a071f6571

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

April 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 185
2 A medical device with a moderate to high risk that requires special controls. 295