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Leaf™

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew Medical, Ltd.

Identity

Trade Name
LEAF™ FDA UDI
Generic Name
Ambulatory monitoring/recording system transceiver/cable FDA UDI
Device Name
Capital equipment to support the Leaf sensor patient montitoring system FDA UDI
Model / Reference
66803065 FDA UDI
Description
Capital equipment to support the Leaf sensor patient montitoring system FDA UDI

Identifiers

Catalog Number
66803065 FDA UDI
Primary DI / UDI-DI
05000223499877 FDA UDI
FDA Product Code
KMI FDA UDI
GMDN Term
Ambulatory monitoring/recording system transceiver/cable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.2400 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ambulatory monitoring/recording system transceiver/cable

Leaf™ by Smith & Nephew Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory monitoring/recording system transceiver/cable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew Medical, Ltd.

Sources (1)

  • FDA UDI f4871bf4-23d0-48d1-a295-7c16b29fbfd6 34 fields · synced May 30, 2026