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EnSite Precision™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
EnSite Precision™ FDA UDI
Generic Name
Medical device storage mount FDA UDI
Device Name
Bedrail Mount Kit FDA UDI
Model / Reference
H702474 FDA UDI
Description
Bedrail Mount Kit FDA UDI

Identifiers

Catalog Number
H702474 FDA UDI
Primary DI / UDI-DI
05415067026316 FDA UDI
510(k) Number
K160210 FDA UDI
K183128 FDA UDI
K201181 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Medical device storage mount FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Category: Medical device storage mount

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

Similar devices

Also classified as Medical device storage mount.

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI f87710a1-4230-494e-8a8f-809a20471f33 37 fields · synced May 30, 2026