Talee

GUDID 00860013898038

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.

INVENT MEDICAL USA LLC

Cranial orthosis
Primary Device ID00860013898038
NIH Device Record Key741324db-e3d8-41f8-9f46-0557efa9e3a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTalee
Version Model NumberTalee w/2in1/Bi-Valve Opening
Company DUNS111474988
Company NameINVENT MEDICAL USA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com
Phone+1 (267) 368-8165
Emailsupport@inventmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860013898038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVAOrthosis, Cranial

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-20
Device Publish Date2025-05-12

On-Brand Devices [Talee]

00860013898038The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positio
00860013898021The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positio
00860013898014The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positio
00860013898007The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positio

Trademark Results [Talee]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TALEE
TALEE
90003467 not registered Live/Pending
Invent Medical Group, s.r.o.
2020-06-16

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