Identity
- Trade Name
- TRAVELER™ Autoclavable Pouch EUDAMEDSCANLAN® TRAVELER™ Autoclavable Pouch FDA UDI
- Generic Name
- Device operating status label/tag, reusable FDA UDI
- Device Name
- SCANLAN® Traveler Autoclavable Pouch EUDAMEDSCANLAN® TRAVELER™ Autoclavable Pouch - Fasteners Not Included, 100/Bx FDA UDI
- Model / Reference
- 1001-951 EUDAMEDFDA UDI
- Description
- SCANLAN® TRAVELER™ Autoclavable Pouch - Fasteners Not Included, 100/Bx FDA UDI
Identifiers
- Catalog Number
- 1001-951 FDA UDI
- Primary DI / UDI-DI
- 00846159024784 EUDAMEDFDA UDI
- Basic UDI-DI
- 08461590TF26LF EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- S9080 DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES EUDAMED
- GMDN Term
- Device operating status label/tag, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- Netherlands 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
No
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
No
FDA UDI
Category: Sterilizer/disinfector rack
TRAVELER™ Autoclavable Pouch by Scanlan International Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 08461590TF26LF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc.
- EUDAMED SRN
- US-MF-000010251
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 1ffa3778-c691-4109-be09-6b61f68556a0 61 fields · synced Jul 25, 2026
- FDA UDI 03d87bdd-6233-45cb-a8a7-e05605c184a2 35 fields · synced May 30, 2026