Getinge Self-Contained BI Steam Vial Box - Self-Contained BI Steam Vial Box - SPS Medical Supply Corp.

Duns Number:194877072

Device Description: Self-Contained BI Steam Vial Box

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More Product Details

Catalog Number

-

Brand Name

Getinge Self-Contained BI Steam Vial Box

Version/Model Number

6005500522

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

FRC

Product Code Name

Indicator, biological sterilization process

Device Record Status

Public Device Record Key

8adac0cc-af16-4364-89de-40289290a9b5

Public Version Date

November 26, 2020

Public Version Number

1

DI Record Publish Date

November 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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