TrenGuard™ - TrenGuard Patient Positioning Kit Hillrom US - - Dan Allen Surgical LLC

Duns Number:040876183

Device Description: TrenGuard Patient Positioning Kit Hillrom US - Includes TrenGuard Patient Support Frame (0 TrenGuard Patient Positioning Kit Hillrom US - Includes TrenGuard Patient Support Frame (00811836030006) and one TrenGuard 600 CLASSIC Pack (00811836030174) in a TrenGuard CarryCase with a case of TrenGuard 450 CLASSIC Packs (20811836030086 12 each 00811836030082)

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More Product Details

Catalog Number

-

Brand Name

TrenGuard™

Version/Model Number

81012

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

a8f121c5-8990-40de-95be-7f356f948c64

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

August 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DAN ALLEN SURGICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28