AccessGUDID - DEVICE: Medicon (04046826057824)

GUDID

Device Identifier (DI) Information

Brand Name: Medicon
Version or Model: 50.93.66
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50.93.66
Company Name: Medicon eG. Chirurgiemechaniker-Genossenschaft

Primary DI Number: 04046826057824
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315492330 *Terms of Use

Device Description: McGivney modif lig instr only

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?
17675	Vessel approximator	One of a pair or set of surgical instruments used to grasp the torn or resected portions of a vessel to hold the portions in apposition for the purpose of reattaching one portion to the other in order to repair the structure. The instrument is also used to grasp a vessel, or separated parts of a vessel, to position it in a surgical opening. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCF	INSTRUMENT, LIGATURE PASSING AND KNOT TYING

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: ee548f24-5378-4f96-9d6f-c1c893b695a9
Public Version Date: December 12, 2024
Public Version Number: 1
DI Record Publish Date: December 04, 2024