Talee

FDA UDI

Class II (US FDA UDI)

by Invent Medical Usa, Llc

Identity

Trade Name: Talee FDA UDI
Generic Name: Cranial orthosis FDA UDI
Device Name: The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects. FDA UDI
Model / Reference: Talee w/One-Side Opening FDA UDI
Description: The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860013898007 FDA UDI
510(k) Number: K241957 FDA UDI
FDA Product Code: MVA FDA UDI
OAN FDA UDI
GMDN Term: Cranial orthosis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5970 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cranial orthosis

Talee by Invent Medical Usa, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K241957 also covers:

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: Invent Medical Usa, Llc

Sources (1)

FDA UDI bc955ce8-be6e-49ae-87bf-b05dc22edade 35 fields · synced Jun 19, 2026