DEVICE: Medicon (04046826160388)

Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Medicon
79.65.24
In Commercial Distribution
79.65.24
Medicon eG. Chirurgiemechaniker-Genossenschaft
04046826160388
GS1

1
315492330 *Terms of Use
Virchow brain knife 38mm 37cm
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45737 Brain knife
A hand-held manual surgical instrument with a handle and an extra long, broad blade used during an autopsy to slice evenly across the entire brain mass of a cadaver to obtain clean cut, cross-sectional, pathological samples. It is typically a one-piece instrument made of high-grade stainless steel; the blade is very broad and thin with a rounded tip. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EMF KNIFE, SURGICAL
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
8cc3745b-e4fe-4f01-8bd6-6880b0e55299
October 02, 2020
1
September 24, 2020
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+490746220090
sales@medicon.de
CLOSE