Sjm™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: SJM™ FDA UDI
Generic Name: Spinal guidewire FDA UDI
Device Name: Guide Wire, 60 cm FDA UDI
Model / Reference: 1771 FDA UDI
Description: Guide Wire, 60 cm FDA UDI

Identifiers

Catalog Number: 1771 FDA UDI
Primary DI / UDI-DI: 05414734401357 FDA UDI
510(k) Number: K110609 FDA UDI
FDA Product Code: LHG FDA UDI
GZB FDA UDI
GMDN Term: Spinal guidewire FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 60 Centimeter FDA UDI

Category: Spinal guidewire

Sjm™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K110609 also covers:

SJM™ — ST. JUDE MEDICAL, INC.
SJM™ — ST. JUDE MEDICAL, 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 II	Pending data

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Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI e4b227b2-19a7-44ff-ae69-6e078339a2ce 38 fields · synced Jun 8, 2026