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Gladius
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PPW14R100P Ref PPW18R100P Ref PPW18R200SRef AP14R323PRef PPW18R200S
Identity
- Trade Name
- Gladius EUDAMEDASAHI Peripheral Guide Wire ASAHI Gladius EUDAMEDASAHI Gladius MG14 300cm Pre-shape EUDAMEDASAHI Gladius Mongo14 FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- Peripheral Guide Wire Astato 30, Astato XS 20, Astato XS 40, Halberd, ASAHI Gaia PV, Gladius, Gladius MG14 PV, Gladius MG14 PV ES, Gladius MG18 PV ES EUDAMEDASAHI Peripheral Guide Wire EUDAMEDASAHI PTCA Guide Wire ASAHI Gladius EUDAMED
- Model / Reference
- PPW14R100P EUDAMEDPPW18R100P EUDAMEDPPW18R200S EUDAMEDAP14R323P EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547327106337 EUDAMED04547327106399 EUDAMED04547327106405 EUDAMED04547327123716 EUDAMEDFDA UDI
- Basic UDI-DI
- 4547327DGW010NY EUDAMEDB-04547327106405 EUDAMEDB-04547327123716 EUDAMED
- FDA Product Code
- DQX FDA UDI
- EMDN Code
- C04020201 PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC EUDAMEDC04030201 INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1330 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMEDEUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.014 Inch FDA UDILength — 300 Centimeter FDA UDI
Gladius by Asahi Intecc Co., Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4547327DGW010NY | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4547327DGW010NY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
- EUDAMED SRN
- JP-MF-000010199
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (6)
- EUDAMED 399a79ea-0d6f-4c11-8693-8b7c86067b29 61 fields · synced Aug 2, 2026
- EUDAMED 52521653-348b-45af-8e96-ccd105f6a5d0 61 fields · synced May 17, 2026
- EUDAMED 85a06441-9de6-4a23-b340-8962179ea113 61 fields · synced May 17, 2026
- EUDAMED 7a1e9a3e-12b8-4757-8407-c6e70719c7ad 61 fields · synced May 18, 2026
- FDA UDI 79be66cd-5d51-4519-af81-5625f214585b 33 fields · synced May 30, 2026
- EUDAMED 0c68f5c5-33af-41a3-86eb-da4a2b7140bc 61 fields · synced Jul 14, 2026