AccessGUDID - DEVICE: DUFNER Instrumente GmbH (04063763199899)

GUDID

Device Identifier (DI) Information

Brand Name: DUFNER Instrumente GmbH
Version or Model: 20913-24
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik

Primary DI Number: 04063763199899
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 327980801 *Terms of Use

Device Description: MICTEC Ovaltrocar for endo-stapler, smooth, Ø 14 mm/ 24 mm, 70 mm long

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?
33678	ENT trocar blade	A rigid, surgical instrument with a sharp pyramidal or conical point used to puncture body cavities during ear/nose/throat (ENT) surgery. It can be assembled and used together with a compatible cannula (not included) filling its lumen, thereby allowing the introduction of this assembly; following puncture, the trocar blade is withdrawn. 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: b127c1f6-af67-4ad2-bbbb-de66f2ec018f
Public Version Date: March 19, 2024
Public Version Number: 1
DI Record Publish Date: March 11, 2024