COMFORT TOUCH - Comfort Touch Insulin Pen Needles 31G 6mm - Slv Pharmaceuticals LLC

Duns Number:081225162

Device Description: Comfort Touch Insulin Pen Needles 31G 6mm

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More Product Details

Catalog Number

-

Brand Name

COMFORT TOUCH

Version/Model Number

INSULIN PEN NEEDLES

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170846,K170846

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

82c1727e-6a50-4cac-ae0d-67d62f8f450a

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SLV PHARMACEUTICALS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 34