SchureMed - Power Beach Chair (EU) - SCHUERCH CORPORATION

Duns Number:964322929

Device Description: Power Beach Chair (EU)

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More Product Details

Catalog Number

-

Brand Name

SchureMed

Version/Model Number

800-0004-EU

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

GBB

Product Code Name

Chair, Surgical, Ac-Powered

Device Record Status

Public Device Record Key

6a19e9f3-2398-4dfa-ac41-28b43951e921

Public Version Date

June 17, 2021

Public Version Number

1

DI Record Publish Date

June 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCHUERCH CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1128