Self-Seal Nylon Pouches
by Crosstex International Inc EUDAMEDGUDID
Active
Ref NSP-405Model Sterilization Packaging
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0732224SterilizationPckV5 | Date11 Jun 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10732224733613 | Date15 Sep 2023 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- Self-Seal Nylon Pouches EUDAMEDNylon Self-Seal Pouch GUDID
- Generic Name
- Sterilization packaging, single-use
- Model / Ref / Catalog
- Sterilization Packaging, NSP-405
- Primary DI / UDI-DI
- 10732224733613
- Basic UDI-DI
- 0732224SterilizationPckV5
- Unit of Use DI
- 00732224733616
- FDA Product Code
- KCT
- EMDN Code
- S010199 Sterilisation pouches - other
- GMDN Term
- Sterilization packaging, single-use
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 880.6850
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000009642
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Crosstex International, Inc.
Properties
Other properties (20)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No