DEVICE: Medicon (04046826015282)

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
09.96.08
In Commercial Distribution
09.96.08
Medicon eG. Chirurgiemechaniker-Genossenschaft
04046826015282
GS1

1
315492330 *Terms of Use
endarterectomy stripper Ø 8.5mm 55cm
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?
31729 Intraluminal artery stripper, reusable
A hand-held manual surgical instrument designed to perform an endarterectomy (the removal of plaque deposits from arteriosclerotic arteries) during a vasculature reconstruction procedure. It is typically made of high-grade stainless steel and is available in various designs including the "MollRing cutter". Indications for its use include disabling claudication, ischemic pain at rest, ischemic skin lesions, or gangrene. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GDI DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
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
623e8d40-a978-40e2-8f96-6ca999823138
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)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+490746220090
sales@medicon.de
CLOSE