AccessGUDID - DEVICE: LIPOcel (08800020100009)

GUDID

Device Identifier (DI) Information

Brand Name: LIPOcel
Version or Model: LIPOcel
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Jeisys Medical Inc.

Primary DI Number: 08800020100009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690275362 *Terms of Use

Device Description: Focused Ultrasound for tissue heat or mechanical cellular disruption

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:	No
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?
40777	Ultrasound hyperthermia system transducer, extracorporeal	An ultrasound (US) transducer assembly that is a component of an ultrasound hyperthermia system used to induce systemic or local body heating of sufficient magnitude to create a targeted therapeutic effect. It is mounted within the gantry or housing of the hyperthermia system or mounted on a floor, wall, or ceiling suspension that allows the operator to position the transducer assembly external to the patient during treatment. It is typically composed of a single transducer element or an array of transducer elements, i.e., piezoelectric or active element(s), or crystal(s) and associated damping, backing, and matching layer materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181896	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: fe2108be-46b0-4f60-9c9a-db5c9fa9b8cf
Public Version Date: March 04, 2020
Public Version Number: 1
DI Record Publish Date: February 25, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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