Identity
- Trade Name
- WIRELESS DR IMAGING OPTION FDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Device Name
- WDR1 Cabinet assembly FDA UDI
- Model / Reference
- WDR1 FDA UDI
- Description
- WDR1 Cabinet assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682106139 FDA UDI
- 510(k) Number
- K102615 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Vascular dilator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vascular dilator, single-use
Wireless Dr Imaging Option by GE Hualun Medical Systems Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular dilator, single-use.
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- Prelude EASE™ — Merit Medical Systems, Inc. · Class II
- Prelude PRO™ — Merit Medical Systems, Inc. · Class II
- Merit MAK™ — Merit Medical Systems, Inc. · Class II
- Merit PAK™ — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K102615 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- GE Hualun Medical Systems Co., Ltd
Sources (1)
- FDA UDI 1008eec9-b237-42c1-bb48-d3b48af5f0ea 34 fields · synced Jun 1, 2026