Steinmann pin w. double end lanzet point 2.8mm/229mm, 6 pcs./unit - Steinmann pin w. double end lanzet - mahe medical gmbh

Duns Number:342243334

Device Description: Steinmann pin w. double end lanzet point2.8mm/229mm, 6 pcs./unit

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More Product Details

Catalog Number

KM71-606

Brand Name

Steinmann pin w. double end lanzet point 2.8mm/229mm, 6 pcs./unit

Version/Model Number

KM71-606

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Device Record Status

Public Device Record Key

4596a885-6571-4cd6-b6ee-30dce7ad380c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 13, 2016

Additional Identifiers

Package DI Number

EMAHKM716061

Quantity per Package

1

Contains DI Package

EMAHKM716060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MAHE MEDICAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 1976