Simpulse SOLO - The Simpulse SOLO Suction/Irrigator - Davol Inc.

Duns Number:001191048

Device Description: The Simpulse SOLO Suction/Irrigator

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More Product Details

Catalog Number

0067570

Brand Name

Simpulse SOLO

Version/Model Number

0067570

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

FQH

Product Code Name

LAVAGE, JET

Device Record Status

Public Device Record Key

5dd7134d-d9e7-4dbb-84c5-3b706b35bb19

Public Version Date

November 06, 2020

Public Version Number

4

DI Record Publish Date

December 23, 2015

Additional Identifiers

Package DI Number

20801741010129

Quantity per Package

2

Contains DI Package

10801741010122

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"DAVOL 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. 348
3 A medical device with high risk that requires premarket approval 18