POSEY - POSEY TAT, WRIST - POSEY PRODUCTS, LLC

Duns Number:008503294

Device Description: POSEY TAT, WRIST

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More Product Details

Catalog Number

2790Q

Brand Name

POSEY

Version/Model Number

2790Q

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)

Yes

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

FMQ

Product Code Name

Restraint, Protective

Device Record Status

Public Device Record Key

94310f8b-4525-4572-9d51-199fac1ccbab

Public Version Date

October 13, 2022

Public Version Number

1

DI Record Publish Date

October 05, 2022

Additional Identifiers

Package DI Number

20190676003376

Quantity per Package

12

Contains DI Package

10190676003379

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