AccessGUDID - DEVICE: Cryoprobe D3.4 mm/10G, 185 mm, Trocar, Elliptic. (07290015487085)

GUDID

Device Identifier (DI) Information

Brand Name: Cryoprobe D3.4 mm/10G, 185 mm, Trocar, Elliptic.
Version or Model: FAP7410000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FAP7410000
Company Name: ICECURE MEDICAL LTD

Primary DI Number: 07290015487085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514758619 *Terms of Use

Device Description: Cryoprobe-Use only with IceCure Cryogenic Device

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":	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?
60508	Hand-held cryosurgical system handpiece tip	A sterile component of a hand-held cryosurgery system intended to be attached to the system handpiece to deliver liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to skin/subcutaneous tissues for cryotherapy applications (e.g., surgical ablation, cosmetic, analgesic). It is typically a closed-end needle intended to deliver focused cooling to the therapy site without destroying healthy tissues. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEH	Unit, Cryosurgical, Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183213	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
Special Storage Condition, Specify: dry, cool, well-ventilated and clean environment without corrosive gas.

Clinically Relevant Size

[?]

Size Type Text
Shaft Length: 185 Millimeter
Needle Gauge: 10 Gauge

Device Record Status

Public Device Record Key: 6018f962-bf56-4957-a4f0-35e115c0da88
Public Version Date: July 11, 2024
Public Version Number: 6
DI Record Publish Date: October 24, 2019