Identity
- Trade Name
- SenSight™ FDA UDI
- Generic Name
- Neurosurgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- ACCY B31040 LEAD TEST CABLE KIT EMN LJ53 FDA UDI
- Model / Reference
- B31040 FDA UDI
- Description
- ACCY B31040 LEAD TEST CABLE KIT EMN LJ53 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000426552 FDA UDI
- FDA Product Code
- MBX FDA UDIMRU FDA UDIPJS FDA UDIMHY FDA UDINHL FDA UDI
- GMDN Term
- Neurosurgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neurosurgical procedure kit, non-medicated, single-use
SenSight™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Neurosurgical procedure kit, non-medicated, single-use.
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Cleared under the same submission
H020007 also covers:
- Activa® PC — MEDTRONIC, INC.
- Activa® PC — MEDTRONIC, INC.
- Activa® SC — MEDTRONIC, INC.
- Activa® SC — MEDTRONIC, INC.
- DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
P960009 also covers:
- Activa® PC — MEDTRONIC, INC.
- Activa® RC — MEDTRONIC, INC.
- Activa® RC — MEDTRONIC, INC.
- Assess ® — MEDTRONIC, INC.
- DBS™ — MEDTRONIC, INC.
- DBS™ — MEDTRONIC, INC.
- Intercept ™ — MEDTRONIC, INC.
- N'VISION 8840 — MEDTRONIC, INC.
- Percept™ PC BrainSense™ — MEDTRONIC, INC.
- SenSight™ — MEDTRONIC, INC.
- SenSight™ — MEDTRONIC, INC.
- SenSight™ — MEDTRONIC, INC.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 397a964d-fdd0-4223-91dd-9b12fa6b7b2c 35 fields · synced Jun 6, 2026