AccessGUDID - DEVICE: Injectra, Sclero Tip (04052838009713)

GUDID

Device Identifier (DI) Information

Brand Name: Injectra, Sclero Tip
Version or Model: GSN-06-19-230
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GSN-06-19-230
Company Name: Medi-Globe GmbH

Primary DI Number: 04052838009713
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 318130267 *Terms of Use

Device Description: Injection Needle / Sclerotherapy Needle , 25 Gauge, needle length 6 mm, tube diameter 1.9 mm, working length 230 cm

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?
38825	General-purpose endoscopic needle, single-use	A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBK	Endoscopic Injection Needle, Gastroenterology-Urology

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: keep dry, keep away form sunlight

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 25 Gauge

Device Record Status

Public Device Record Key: 10e4f191-63e6-41b5-9616-6a7eff105815
Public Version Date: May 23, 2019
Public Version Number: 1
DI Record Publish Date: May 15, 2019