AccessGUDID - DEVICE: Medicon (04046826472085)

GUDID

Device Identifier (DI) Information

Brand Name: Medicon
Version or Model: 58.82.28
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 58.82.28
Company Name: Medicon eG. Chirurgiemechaniker-Genossenschaft

Primary DI Number: 04046826472085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315492330 *Terms of Use

Device Description: template 38x22mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
60909	Sterilization container filter, single-use	A device designed to function as a microbial barrier in containers used for steam or solvent sterilization. It allows penetration of the sterilization agent as it prevents the passage of microorganisms. It is typically made of a thin, porous, non-woven fabric material or paper. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWT	Template

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: 54243300-dff3-46ed-adc9-916be102b7b5
Public Version Date: March 27, 2026
Public Version Number: 1
DI Record Publish Date: March 19, 2026