Coleman Mini Style I Kit, 19g x 5cm with Stylet - Coleman Mini Style I Kit, 19g x 5cm Cannula with - MENTOR TEXAS L.P.

Duns Number:167450993

Device Description: Coleman Mini Style I Kit, 19g x 5cm Cannula with Stylet

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More Product Details

Catalog Number

COL-MINI I-K

Brand Name

Coleman Mini Style I Kit, 19g x 5cm with Stylet

Version/Model Number

COL-MINI I-K

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

-

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Record Status

Public Device Record Key

f647c921-7e2e-445b-b6d5-55cfcbdf5223

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MENTOR TEXAS L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 128
3 A medical device with high risk that requires premarket approval 545
U Unclassified 514