AccessGUDID - DEVICE: Ablapak (03661690000014)

GUDID

Device Identifier (DI) Information

Brand Name: Ablapak
Version or Model: TMS 227710
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EDAP-TMS FRANCE

Primary DI Number: 03661690000014
Issuing Agency: GS1
Commercial Distribution End Date: May 24, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 383113362 *Terms of Use

Device Description: The Ablapak is he single use kit of consumables to support a single patient procedure using the Ablatherm Integrated Imaging system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
11248	Physical therapy ultrasound system	An assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PLP	High Intensity Ultrasound System For Prostate Tissue Ablation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153023	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
Storage Environment Temperature: between 40 and 100 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 823d77db-07dc-466b-a9bc-008f3b949f2a
Public Version Date: December 11, 2024
Public Version Number: 2
DI Record Publish Date: June 08, 2018