Duns Number:051512253
Device Description: Sterile Aquasonic 100 Ultrasound Transmission Gel may be used:• On or near broken skin, su 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 indicated.• On mucous membranes and in natural body orifices.• For patients where cross contamination is a concern such as:• Patients with immunodeficiency or on immunosuppressive therapy.• Neonates or critically ill pediatric patients.• Critically ill patients or patients in contact, airborne or droplet transmission-based precautions.
Catalog Number
CAT447-Q06
Brand Name
Sterile Aquasonic 100 Ultrasound Transmission Gel
Version/Model Number
MS303
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K172529,K172529
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
a8959ef7-30f2-4d3f-8d5e-a3a57d812cf2
Public Version Date
February 18, 2019
Public Version Number
6
DI Record Publish Date
December 19, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |