AccessGUDID - DEVICE: ERMIS (04049224288685)

GUDID

Device Identifier (DI) Information

Brand Name: ERMIS
Version or Model: ER800.000E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ER800.000E
Company Name: Ermis MedTech GmbH

Primary DI Number: 04049224288685
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313118522 *Terms of Use

Device Description: Single-use paper filter, pack of 100 pcs, for 1/1, 1/2, 3/4 containers, ø 190 mm

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 6b672a10-9a31-41a2-9e27-adc673c8f8ec
Public Version Date: October 15, 2025
Public Version Number: 1
DI Record Publish Date: October 07, 2025