AccessGUDID - DEVICE: Gangi-SoftGuard Coaxial Needle (07350031350364)

GUDID

Device Identifier (DI) Information

Brand Name: Gangi-SoftGuard Coaxial Needle
Version or Model: G036
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SG13-171
Company Name: Apriomed AB

Primary DI Number: 07350031350364
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631734758 *Terms of Use

Device Description: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 13G x 17.1 cm.

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?
45018	Needle guide, single-use	A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCG	Biopsy Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181756	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
Length: 17.1 Centimeter
Needle Gauge: 13 Gauge

Device Record Status

Public Device Record Key: a6408c76-e5e1-4a94-9ff4-7bf652d2a944
Public Version Date: February 16, 2024
Public Version Number: 3
DI Record Publish Date: April 24, 2023