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On-Point®

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
ON-POINT® FDA UDI
Generic Name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI
Device Name
LEAD 3987A ON-POINT 1X4 PNS 25CM ID FDA UDI
Model / Reference
3987A FDA UDI
Description
LEAD 3987A ON-POINT 1X4 PNS 25CM ID FDA UDI

Identifiers

Primary DI / UDI-DI
00673978926452 FDA UDI
510(k) Number
K040568 FDA UDI
FDA Product Code
GZF FDA UDI
GMDN Term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5870 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

On-Point® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection.

Cleared under the same submission

K040568 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 9df27028-0f1d-4efb-baeb-dd00a7b00f91 36 fields · synced May 30, 2026