Identity
- Trade Name
- Stoma Sizing Guide (50 pcs) EUDAMEDFDA UDI
- Generic Name
- Tracheostoma sizer FDA UDI
- Device Name
- Stoma sizing guide EUDAMEDStoma Sizing Guide is a single use device intended to help the prescribing clinician determine which size of LaryTube or LaryButton in the Provox and Provox Life™ range respectively should be prescribed to the patient. Stoma Sizing Guide is intended to be used by a prescribing clinician who has read the IFU for Provox and Provox Life™ LaryTube and LaryButton respectively. Stoma Sizing Guide can also be used by patients to monitor the stoma size. FDA UDI
- Model / Reference
- 7135 EUDAMEDFDA UDI
- Description
- Stoma Sizing Guide is a single use device intended to help the prescribing clinician determine which size of LaryTube or LaryButton in the Provox and Provox Life™ range respectively should be prescribed to the patient. Stoma Sizing Guide is intended to be used by a prescribing clinician who has read the IFU for Provox and Provox Life™ LaryTube and LaryButton respectively. Stoma Sizing Guide can also be used by patients to monitor the stoma size. FDA UDI
Identifiers
- Catalog Number
- 7135 FDA UDI
- Primary DI / UDI-DI
- 07331791015366 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-LTU-0-000-0006-3S EUDAMED
- Unit of Use DI
- 07331791016783 EUDAMED
- FDA Product Code
- LRC FDA UDI
- EMDN Code
- R01058099 TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES EUDAMED
- GMDN Term
- Tracheostoma sizer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Stoma Sizing Guide (50 pcs) by Atos Medical AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7331791-LTU-0-000-0006-3S | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical AB
- EUDAMED SRN
- SE-MF-000000725
Sources (2)
- EUDAMED e0fc07fc-e93b-42d4-8f9e-c6b73e6b660c 61 fields · synced Oct 6, 2026
- FDA UDI a9920523-1a35-41d5-8cba-14db4b085bd1 36 fields · synced May 30, 2026