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Sjm™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
SJM™ FDA UDI
Generic Name
Epidural needle, non-threaded FDA UDI
Model / Reference
1773 FDA UDI

Identifiers

Catalog Number
1773 FDA UDI
Primary DI / UDI-DI
05414734403962 FDA UDI
510(k) Number
K110609 FDA UDI
FDA Product Code
LHG FDA UDI
GZB FDA UDI
GMDN Term
Epidural needle, non-threaded 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

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

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 19 Centimeter FDA UDI

Category: Epidural needle, non-threaded

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

Similar devices

Also classified as Epidural needle, non-threaded.

Cleared under the same submission

K110609 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI 2b137004-a136-4914-9489-9463d369dc6d 37 fields · synced Jun 8, 2026