AccessGUDID - DEVICE: Olympus (04042761000185)

GUDID

Device Identifier (DI) Information

Brand Name: Olympus
Version or Model: 00126
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00126
Company Name: OLYMPUS Winter & Ibe GmbH

Primary DI Number: 04042761000185
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 316957240 *Terms of Use

Device Description: Cannula, 7 Fr., flexible

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:	No
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?
38824	General-purpose endoscopic needle, reusable	A flexible 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 reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCP	Endoscope, Ac-Powered And Accessories

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 29a6748e-a367-4937-98f9-b047dfc68231
Public Version Date: August 16, 2022
Public Version Number: 4
DI Record Publish Date: September 21, 2016