POSEY - LATERAL WEDGE, LARGE - POSEY PRODUCTS, LLC

Duns Number:008503294

Device Description: LATERAL WEDGE, LARGE

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More Product Details

Catalog Number

6309L

Brand Name

POSEY

Version/Model Number

6309L

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

FNL

Product Code Name

Bed, Ac-Powered Adjustable Hospital

Device Record Status

Public Device Record Key

2516baa9-6c04-4f8a-a059-df4cfdf7a166

Public Version Date

October 12, 2022

Public Version Number

1

DI Record Publish Date

October 04, 2022

Additional Identifiers

Package DI Number

20190676005585

Quantity per Package

4

Contains DI Package

10190676005588

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"POSEY PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 177
2 A medical device with a moderate to high risk that requires special controls. 77