Ultrasound Transmission Gel

GUDID 17350025911660

Vitrolife Sweden AB

Coupling gel, non-sterile Coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel
Primary Device ID17350025911660
NIH Device Record Keyf0abd4c5-471e-446f-8520-23f612334ade
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasound Transmission Gel
Version Model Number14203
Company DUNS631805488
Company NameVitrolife Sweden AB
Device Count25
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107350025911663 [Unit of Use]
GS117350025911660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOTElectrode, Gel, Electrosurgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-13

Devices Manufactured by Vitrolife Sweden AB

07350025910901 - EmbryoGlue2022-02-07
07350025910765 - HYASE-10X2022-01-10
07350025910833 - HYASE-10X2021-07-01
07350025910796 - G-RINSE2021-06-04
07350025910802 - ASP2021-06-04
07350025910819 - G-MOPS2021-06-04
07350025910826 - G-MOPS PLUS2021-06-04
07350025910604 - Gx-IVF2021-05-31

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