Simpulse PLUS 0057700

GUDID 10801741065283

Simpulse PLUS System with Ultrex Retractable Splash Shield Tip (1.75" diameter) Tip, Suction Tubing, and Dual Spike Adapter

Davol Inc.

Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system
Primary Device ID10801741065283
NIH Device Record Key78768f22-d240-4347-81f9-9652443f2220
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimpulse PLUS
Version Model Number0057700
Catalog Number0057700
Company DUNS001191048
Company NameDavol Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741065286 [Primary]
GS110801741065283 [Package]
Contains: 00801741065286
Package: BX [5 Units]
In Commercial Distribution
GS120801741065280 [Package]
Package: CA [2 Units]
In Commercial Distribution

FDA Product Code

FQHLAVAGE, JET

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-21
Device Publish Date2015-12-23

On-Brand Devices [Simpulse PLUS]

10801741065283Simpulse PLUS System with Ultrex Retractable Splash Shield Tip (1.75" diameter) Tip, Suction Tub
10801741065276Simpulse Plus System with Showerhead Tip, Suction Tubing, and Dual Spike Adapter
10801741065269Simpulse Plus System with Soft Splash Shield Tip, Suction Tubing, and Dual Spike Adapter
20801741065259Simpulse Plus Suction/Irrigator

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