N/A - STANDARD REMOTE INJECTION PORT WITH SUTURE DISK - PMT CORPORATION

Duns Number:039576871

Device Description: STANDARD REMOTE INJECTION PORT WITH SUTURE DISK

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More Product Details

Catalog Number

3608-21

Brand Name

N/A

Version/Model Number

3608-21

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)

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

d683f83e-cae7-47b9-8658-c0fbfb5cf780

Public Version Date

September 23, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PMT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 673
2 A medical device with a moderate to high risk that requires special controls. 8273
U Unclassified 1188