AccessGUDID - DEVICE: SOMATEX (08033860021856)

GUDID

Device Identifier (DI) Information

Brand Name: SOMATEX
Version or Model: SOMACORE VERIFY S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 900502-US
Company Name: BIOPSYBELL SRL

Primary DI Number: 08033860021856
Issuing Agency: GS1
Commercial Distribution End Date: April 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 438746708 *Terms of Use

Device Description: No description.

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":	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?
16835	Soft-tissue biopsy procedure kit, non-medicated	A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCG	Biopsy Needle
KNW	Instrument, Biopsy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130616	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: 150 Millimeter
Needle Gauge: 18 Gauge

Device Record Status

Public Device Record Key: f7eb92b5-591a-48b8-a638-3c1d8b316cf5
Public Version Date: April 29, 2025
Public Version Number: 5
DI Record Publish Date: August 01, 2016