Sterile Aquasonic 100 Ultrasound Transmission Gel CAT447-Q06

GUDID 28886479300157

Sterile Aquasonic 100 Ultrasound Transmission Gel may be used: • On or near broken skin, such as fresh surgical site or open wound where sterility is

AERIN MEDICAL INC.

Electrosurgical system
Primary Device ID28886479300157
NIH Device Record Keya8959ef7-30f2-4d3f-8d5e-a3a57d812cf2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile Aquasonic 100 Ultrasound Transmission Gel
Version Model NumberMS303
Catalog NumberCAT447-Q06
Company DUNS051512253
Company NameAERIN MEDICAL INC.
Device Count6
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8334848237
Emailcustomerservice@aerinmedical.c
Phone8334848237
Emailcustomerservice@aerinmedical.c
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108886479300153 [Unit of Use]
GS128886479300157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-02-18
Device Publish Date2017-12-19

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