FDA UDI
In Commercial Distribution
🇺🇸 United States
ERMIS
DI: 04049224309618
·
Model: ER805.000
·
Ermis MedTech GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ERMIS
- Primary DI
- 04049224309618
- Version / Model
- ER805.000
- Catalog Number
- ER805.000
- Company Name
- Ermis MedTech GmbH
- Labeler DUNS
- 313118522
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-07
- Public Version
- 1
- Public Version Date
- 2025-10-15
- Public Version Status
- New
- Public Device Record Key
- 6981563e-d1c4-4844-89c9-0125b298814c
Device Description
Single-Use paper filter, pack of 100 pcs, for 1/2 Dental Container, 125x95 mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049224309618 | GS1 |
Customer Contacts
- Phone
- +4974619648570
- [email protected]