RELI - Epidural Needle, Detachable Wing, Yellow - MYCO MEDICAL SUPPLIES INC.

Duns Number:879187821

Device Description: Epidural Needle, Detachable Wing, Yellow

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More Product Details

Catalog Number

-

Brand Name

RELI

Version/Model Number

TU20G451

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

57f8c3d1-f2f6-4e54-af0e-d6b2c404df55

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20386120007124

Quantity per Package

4

Contains DI Package

10386120007127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MYCO MEDICAL SUPPLIES INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 471