MEDICOM PRO-TIP TURBO - MEDICOM PRO-TIP TURBO AIR/WATER SYRINGE - AMD Medicom Inc

Duns Number:256880576

Device Description: MEDICOM PRO-TIP TURBO AIR/WATER SYRINGE

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More Product Details

Catalog Number

1007073

Brand Name

MEDICOM PRO-TIP TURBO

Version/Model Number

1007073

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ECB

Product Code Name

Unit, Syringe, Air And/Or Water

Device Record Status

Public Device Record Key

dc4de926-59e3-4dba-aa3e-c6f27c2b741b

Public Version Date

March 26, 2019

Public Version Number

1

DI Record Publish Date

March 18, 2019

Additional Identifiers

Package DI Number

20686864054911

Quantity per Package

6

Contains DI Package

10686864054914

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer case

"AMD MEDICOM INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 84
2 A medical device with a moderate to high risk that requires special controls. 27
U Unclassified 2