Identity
- Trade Name
- Dornier MedTech FDA UDI
- Generic Name
- Gastro-urological guidewire, single-use FDA UDI
- Device Name
- PTFE Coated Stainless Steel Guidewire, 0.035" diameter, 150 cm length, 3 cm tip. FDA UDI
- Model / Reference
- APP3515S FDA UDI
- Description
- PTFE Coated Stainless Steel Guidewire, 0.035" diameter, 150 cm length, 3 cm tip. FDA UDI
Identifiers
- Catalog Number
- 48012512 FDA UDI
- Primary DI / UDI-DI
- 00810116020553 FDA UDI
- FDA Product Code
- EYA FDA UDI
- GMDN Term
- Gastro-urological guidewire, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
MR Unsafe FDA UDI
Category: Gastro-urological guidewire, single-use
Dornier MedTech by Dornier MedTech America, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastro-urological guidewire, single-use.
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- aneopiston — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
- Tracer Metro — COOK INCORPORATED · Class II
- Sterile Hydro-Slide Guidewire — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Single Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class II
- Führungsdraht, "Grip-Wire", Nitinol — MTW - Endoskopie W. Haag KG · Class IIa
- Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
- Optimos™ Guidewire — Taewoong Medical · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dornier MedTech America, Inc.
Sources (1)
- FDA UDI c20a6beb-f650-4cdd-bcd5-14d54237808c 34 fields · synced Jun 9, 2026