AccessGUDID - DEVICE: HS AMICA (08058983741054)

GUDID

Device Identifier (DI) Information

Brand Name: HS AMICA
Version or Model: RF AMICA-PROBE
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RF18100E07V1
Company Name: H.S. HOSPITAL SERVICE SPA

Primary DI Number: 08058983741054
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 428898555 *Terms of Use

Device Description: RF AMICA-PROBE 18GX100MM EXP. TIP 7MM

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
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?
40794	Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal	A component of a radio-frequency (RF) hyperthermia system designed to be placed in the body to deliver radio-frequency (RF) energy to produce a systemic or local heating effect for the treatment of malignant or benign tumours, or other disease conditions. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of RF energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the probe during operation. This is a single-use device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150112	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
Needle Gauge: 18 Gauge
Length: 100 Millimeter

Device Record Status

Public Device Record Key: 7e53eebd-075f-4e14-8e7a-5abbceeb35e6
Public Version Date: January 10, 2025
Public Version Number: 2
DI Record Publish Date: March 01, 2021