FDA UDI In Commercial Distribution 🇺🇸 United States

DUFNER Instrumente GmbH

DI: 04063763186493 · Model: 26943-02 · DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DUFNER Instrumente GmbH
Primary DI
04063763186493
Version / Model
26943-02
Company Name
DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
Labeler DUNS
327980801
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-03-11
Public Version
2
Public Version Date
2024-07-25
Public Version Status
Update
Public Device Record Key
506aca7e-ca1d-4239-9105-73adbde660d3

Device Description

MICTEC Suction-irrigation tube, Ø 5 mm with large Luer-Lock connection, small central opening

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
GCJ Laparoscope, General & Plastic Surgery

GMDN Terms

Code Name
61793 Endoscope suction valve, reusable

Identifiers

Type ID
Primary 04063763186493

Premarket Submissions

Submission Number Supplement Number
K002877 000