Identity
- Trade Name
- ReShape Medical™ Guidewire FDA UDI
- Generic Name
- General-purpose non-vascular guidewire FDA UDI
- Device Name
- ReShape Medical™ Guidewire .035” x 260 cm, 13 cm (Straight Tip) FDA UDI
- Model / Reference
- RSM300 FDA UDI
- Description
- ReShape Medical™ Guidewire .035” x 260 cm, 13 cm (Straight Tip) FDA UDI
Identifiers
- Catalog Number
- RSM300 FDA UDI
- Primary DI / UDI-DI
- 00850758007109 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- General-purpose non-vascular guidewire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1330 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
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 — 0.035 Inch FDA UDILength — 260 Centimeter FDA UDI
Category: General-purpose non-vascular guidewire
ReShape Medical™ Guidewire by Techdevice Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose non-vascular guidewire.
- Jagwire — Boston Scientific · Class II
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- RX Cholangiogram Kit — Boston Scientific · Class II
- PTFE Coated Urological Guidewire — LAKE REGION MEDICAL LIMITED · Class I
- GLIDEWIRE — Terumo Corp. · Class II
- GLIDEWIRE — Terumo Corp. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Techdevice Corporation
Sources (1)
- FDA UDI 98717a7d-165f-46e0-bd34-31081d3a0d05 35 fields · synced May 30, 2026