AccessGUDID - DEVICE: DUFNER Instrumente GmbH (04063763200793)

GUDID

Device Identifier (DI) Information

Brand Name: DUFNER Instrumente GmbH
Version or Model: 20941-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik

Primary DI Number: 04063763200793
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 327980801 *Terms of Use

Device Description: MICTEC Injection cannula, 30° curved, with small Luer-Lock, Ø 5.0 mm, G 22, 300 mm working length

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?
61793	Endoscope suction valve, reusable	A device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002877	000

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: 0a27b1f1-20e9-4c00-810a-2e18fc47f3b3
Public Version Date: July 25, 2024
Public Version Number: 2
DI Record Publish Date: March 11, 2024