Alleset - Impervious Pillow - GRI Medical & Electronic Technology Co., Ltd.

Duns Number:679894738

Device Description: Impervious Pillow Cover_Blue_20"X27"_Bulk_N/S_50ea/cs

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More Product Details

Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 50-PC1927

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

KME

Product Code Name

BEDDING, DISPOSABLE, MEDICAL

Device Record Status

Public Device Record Key

7605143a-bbcd-4917-85da-286f92eae19a

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 27, 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