Identity
- Trade Name
- Guidewire FDA UDI
- Generic Name
- Peripheral vascular guidewire, manual FDA UDI
- Device Name
- Guidewire FDA UDI
- Model / Reference
- SGW-035-04 FDA UDI
- Description
- Guidewire FDA UDI
Identifiers
- Catalog Number
- SGW-035-04 FDA UDI
- Primary DI / UDI-DI
- 00841268101067 FDA UDI
- 510(k) Number
- K021990 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Peripheral vascular guidewire, manual 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.035 Inch FDA UDI
Category: Peripheral vascular guidewire, manual
Guidewire by Galt Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Peripheral vascular guidewire, manual.
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- GO2WIRE™ — Merit Medical Systems, Inc. · Class II
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- Selectiva — HERAEUS MEDICAL COMPONENTS LLC · Class II
Cleared under the same submission
K021990 also covers:
- B.BRAUN — B BRAUN INTERVENTIONAL SYSTEMS, INC
- B.BRAUN — B BRAUN INTERVENTIONAL SYSTEMS, INC
- B.BRAUN — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Guidewire — Galt Medical Corp.
- Guidewire — Galt Medical Corp.
- Guidewire — Galt Medical Corp.
- Guidewire — Galt Medical Corp.
- Guidewire — Galt Medical Corp.
- Guidewire — Galt Medical Corp.
- Guidewire — Galt Medical Corp.
- Guidewire — Galt Medical Corp.
- Guidewire — Galt Medical Corp.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Galt Medical Corp.
Sources (1)
- FDA UDI d5359def-2bfb-4356-861a-598c012e55d8 37 fields · synced May 30, 2026