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Kmedic

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
KMEDIC FDA UDI
Generic Name
Orthosis suspension unit FDA UDI
Device Name
LEAD HAND ADULT 9 1/2" 2 MILLIMETER THICK FDA UDI
Model / Reference
IPN014729 FDA UDI
Description
LEAD HAND ADULT 9 1/2" 2 MILLIMETER THICK FDA UDI

Identifiers

Catalog Number
KM49093 FDA UDI
Primary DI / UDI-DI
24026704281064 FDA UDI
FDA Product Code
GAD FDA UDI
GMDN Term
Orthosis suspension unit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthosis suspension unit

Kmedic by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthosis suspension unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 4f57c8e2-eb7c-4adf-a4e7-be5c4fd26c1d 35 fields · synced Jun 8, 2026