Streamline PLUS - Streamline PLUS XTTB Insert, 30K - HU-FRIEDY MFG. CO., LLC

Duns Number:005085972

Device Description: Streamline PLUS XTTB Insert, 30K

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More Product Details

Catalog Number

UI30SPXTTB

Brand Name

Streamline PLUS

Version/Model Number

UI30SPXTTB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

ELC

Product Code Name

Scaler, ultrasonic

Device Record Status

Public Device Record Key

176b8f9a-7eae-4653-bbb5-4d281ebf7cad

Public Version Date

October 21, 2019

Public Version Number

1

DI Record Publish Date

October 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HU-FRIEDY MFG. CO., LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7436
2 A medical device with a moderate to high risk that requires special controls. 238