hole-in-none - Edge Guard - General Hospital Supply Corp

Duns Number:055852834

Device Description: Edge Guard

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More Product Details

Catalog Number

4800

Brand Name

hole-in-none

Version/Model Number

4800

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

LRP

Product Code Name

Tray, Surgical

Device Record Status

Public Device Record Key

3219deb8-8ab5-422f-ba25-3fcbff6dec6e

Public Version Date

September 23, 2022

Public Version Number

1

DI Record Publish Date

September 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENERAL HOSPITAL SUPPLY CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 53
2 A medical device with a moderate to high risk that requires special controls. 1