Identity
- Trade Name
- Specify® SureScan® FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI
- Device Name
- LEAD 977C190 SPECIFY SRSCN 565 SRG EMAN FDA UDI
- Model / Reference
- 977C190 FDA UDI
- Description
- LEAD 977C190 SPECIFY SRSCN 565 SRG EMAN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000324216 FDA UDI
- PMA Number
- P840001 FDA UDI
- FDA Product Code
- QRB FDA UDILGW FDA UDI
- GMDN Term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection 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
Yes
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
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 90.0 Centimeter FDA UDI
Specify® SureScan® by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection.
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Cleared under the same submission
P840001 also covers:
- ITREL® EZ ™ — MEDTRONIC, INC.
- Injex® — MEDTRONIC, INC.
- Intellis™ — MEDTRONIC, INC.
- Itrel® — MEDTRONIC, INC.
- Itrel® EZ — MEDTRONIC, INC.
- N'VISION® — MEDTRONIC, INC.
- N'VISION 8840 — MEDTRONIC, INC.
- PISCES-QUAD PLUS ™ — MEDTRONIC, INC.
- PISCES-QUAD PLUS ™ — MEDTRONIC, INC.
- PISCES-QUAD® — MEDTRONIC, INC.
- RESUME ® TL — MEDTRONIC, INC.
- Specify® SureScan® MRI 5-6-5 — 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 af7f8511-f5ba-4f13-805a-082a70fa1398 36 fields · synced May 30, 2026