PMI - PMI Tungsten Micro Needle 3cm 45° Angle, 1 cm - PROGRESSIVE MEDICAL, INC.

Duns Number:192135242

Device Description: PMI Tungsten Micro Needle 3cm 45° Angle, 1 cm from tip

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More Product Details

Catalog Number

P1653

Brand Name

PMI

Version/Model Number

P1653

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)

-

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

4307f1b2-64a6-43d1-a858-3bad9085a45a

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10812608020710

Quantity per Package

10

Contains DI Package

00812608020713

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"PROGRESSIVE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 112