Alleset - Valueselect* Gown_Reniforcement_Medium_35g - GRI Medical & Electronic Technology Co., Ltd.

Duns Number:679894738

Device Description: Valueselect* Gown_Reniforcement_Medium_35g SMS_Non Sterile_459ea/cs

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More Product Details

Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 46677-00

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

K102652,K102652,K102652

Product Code Details

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Device Record Status

Public Device Record Key

f42ecdac-65ee-4aba-b5ee-03cb19acef33

Public Version Date

December 27, 2021

Public Version Number

2

DI Record Publish Date

April 22, 2021

Additional Identifiers

Package DI Number

26931918190409

Quantity per Package

27

Contains DI Package

16931918190402

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"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