Medline - NDL,TUOHY EPID,17GX3.5",PLASTIC STYLET - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: NDL,TUOHY EPID,17GX3.5",PLASTIC STYLET

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More Product Details

Catalog Number

PAIN8001

Brand Name

Medline

Version/Model Number

PAIN8001

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"

Yes

For Single-Use

Yes

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

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Record Status

Public Device Record Key

7d742aa3-d118-4be8-891c-a66287f34d2d

Public Version Date

February 04, 2021

Public Version Number

1

DI Record Publish Date

January 27, 2021

Additional Identifiers

Package DI Number

30884389619975

Quantity per Package

25

Contains DI Package

10884389619971

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7