NA - ROLL-A-SET Disposable Instrument Protector Packs - STERIS CORPORATION

Duns Number:961394798

Device Description: ROLL-A-SET Disposable Instrument Protector Packs - 10 Pocket are foam rolls and used to pr ROLL-A-SET Disposable Instrument Protector Packs - 10 Pocket are foam rolls and used to protect delicate or sharp instruments from damage, organize instruments, and prevent sterilization package puncture.

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More Product Details

Catalog Number

851210

Brand Name

NA

Version/Model Number

Roll-A-Set

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Record Status

Public Device Record Key

bf71859a-1d84-46ba-8db1-ca5e449bf6e0

Public Version Date

April 08, 2021

Public Version Number

1

DI Record Publish Date

March 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERIS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1528
2 A medical device with a moderate to high risk that requires special controls. 1557