Acrobat 2 Calibrated Tip Wire Guide
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Acrobat FDA UDI
- Generic Name
- Gastro-urological guidewire, single-use FDA UDI
- Device Name
- ACROBAT 2 CALIBRATED TIP WIRE GUIDE EUDAMEDFDA UDI
- Model / Reference
- AWG2-35-450 EUDAMEDG47616 FDA UDI
- Description
- Acrobat 2 Calibrated Tip Wire Guide FDA UDI
Identifiers
- Catalog Number
- AWG2-35-450 FDA UDI
- Primary DI / UDI-DI
- 00827002476165 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002476165 EUDAMED
- FDA Product Code
- OCY FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Gastro-urological guidewire, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Gastro-urological guidewire, single-use
Acrobat 2 Calibrated Tip Wire Guide by Wilson-Cook Medical, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, 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
Manufacturer's product page: Acrobat® 2 Calibrated Tip Wire Guide
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00827002476165 | Class I | Active |
| 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
- Wilson-Cook Medical, Inc.
- EUDAMED SRN
- US-MF-000002658
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (2)
- EUDAMED f2c58aa5-fd95-417a-9ced-7ef4d1093a8b 61 fields · synced Jul 9, 2026
- FDA UDI 7849572b-4709-4cde-a1e0-34a5f569d54d 36 fields · synced May 30, 2026