GC SPRAY-CIDE™ - GC SPRAY-CIDE™ One Gallon Refill (3.8L) - Gc America Inc.

Duns Number:005473608

Device Description: GC SPRAY-CIDE™ One Gallon Refill (3.8L)

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More Product Details

Catalog Number

555128

Brand Name

GC SPRAY-CIDE™

Version/Model Number

555128

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 14, 2021

Issuing Agency

In HIBCC

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

LRJ

Product Code Name

Disinfectant, medical devices

Device Record Status

Public Device Record Key

1f76c160-3668-4b94-b076-cc88ab8474bf

Public Version Date

September 15, 2021

Public Version Number

3

DI Record Publish Date

February 10, 2017

Additional Identifiers

Package DI Number

D6585551282

Quantity per Package

4

Contains DI Package

D6585551281

Package Discontinue Date

July 28, 2020

Package Status

Not in Commercial Distribution

Package Type

-

"GC AMERICA INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 480
2 A medical device with a moderate to high risk that requires special controls. 4772