N/A - Cysto Adapters - DORNOCH MEDICAL SYSTEMS, INC.

Duns Number:004687018

Device Description: Cysto Adapters

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More Product Details

Catalog Number

TP-CYSTO

Brand Name

N/A

Version/Model Number

TP-CYSTO

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

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

GCY

Product Code Name

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Device Record Status

Public Device Record Key

83de66da-4ff8-4cc4-9b60-adc64966558a

Public Version Date

May 11, 2022

Public Version Number

2

DI Record Publish Date

November 16, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DORNOCH MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 2