AccessGUDID - DEVICE: Sterile Aquasonic 100 Ultrasound Transmission Gel (28886479300157)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile Aquasonic 100 Ultrasound Transmission Gel
Version or Model: MS303
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAT447-Q06
Company Name: Aerin Medical Inc.

Primary DI Number: 28886479300157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 051512253 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44776	Electrosurgical system	An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172529	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a8959ef7-30f2-4d3f-8d5e-a3a57d812cf2
Public Version Date: April 21, 2023
Public Version Number: 8
DI Record Publish Date: December 19, 2017