Identity
- Trade Name
- Guardian Intraoperative Lead, Small FDA UDI
- Generic Name
- Nerve-locating system FDA UDI
- Device Name
- The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Small size has lead body width of approximately 4mm. FDA UDI
- Model / Reference
- 9524 FDA UDI
- Description
- The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Small size has lead body width of approximately 4mm. FDA UDI
Identifiers
- Catalog Number
- 9524 FDA UDI
- Primary DI / UDI-DI
- B13095240 FDA UDI
- 510(k) Number
- K212355 FDA UDI
- FDA Product Code
- ETN FDA UDI
- GMDN Term
- Nerve-locating system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1820 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
- Width — 4 Millimeter FDA UDI
Category: Nerve-locating system
Guardian Intraoperative Lead, Small by Checkpoint Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212355 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
- Checkpoint Surgical, Inc.
Sources (1)
- FDA UDI 3c3d120f-def7-41c0-9b1d-3dc9fdbb677d 37 fields · synced May 30, 2026