Motion Medical Distributing - #1704 Obstetrical Kit - Haslam Medical, Inc.

Duns Number:604208868

Device Description: #1704 Obstetrical Kit

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More Product Details

Catalog Number

1704

Brand Name

Motion Medical Distributing

Version/Model Number

1704

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

OKV

Product Code Name

Obstetrical Kit

Device Record Status

Public Device Record Key

7eb325f6-2a63-4c48-9fb5-d6459473f3eb

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

March 24, 2017

Additional Identifiers

Package DI Number

25060498451400

Quantity per Package

10

Contains DI Package

15060498451403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"HASLAM MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 190