AccessGUDID - DEVICE: SonoTip Pro Control (04052838014083)

GUDID

Device Identifier (DI) Information

Brand Name: SonoTip Pro Control
Version or Model: GUS-33-27-025-04
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GUS-33-27-025-04
Company Name: Medi-Globe GmbH

Primary DI Number: 04052838014083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 318130267 *Terms of Use

Device Description: SonoTip Pro Control Endoscopic Ultrasound Needle, EUS-FNA, 25 G, Needle Length 0 - 8.5 cm, Sheath Diameter 2.7 mm, round stylet

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":	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?
10403	Ultrasound aspiration biopsy procedure kit	A collection of sterile devices that includes a biopsy needle and other supplies used to perform an ultrasound-guided aspiration sampling of tissue. The needle tip must provide a clearly visible image during ultrasound imaging. 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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Please store the instrument at room temperature, keep dry and avoid exposure to sunlight

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 25 Gauge

Device Record Status

Public Device Record Key: 7343565b-592f-4202-8fbd-bd67d2a6f981
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016