STEAM INDICATOR LABEL - Labels that provide a distinct color change when - SPS Medical Supply Corp.

Duns Number:194877072

Device Description: Labels that provide a distinct color change when exposed to the appropriate sterilization Labels that provide a distinct color change when exposed to the appropriate sterilization process

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More Product Details

Catalog Number

SIL-1000

Brand Name

STEAM INDICATOR LABEL

Version/Model Number

SIL-1000

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

JOJ

Product Code Name

Indicator, physical/chemical sterilization process

Device Record Status

Public Device Record Key

f5690fd7-0e5b-41b8-bf69-693d8549bd5d

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

November 15, 2016

Additional Identifiers

Package DI Number

50732224710063

Quantity per Package

10

Contains DI Package

10732224710065

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

roll

"SPS MEDICAL SUPPLY CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 26