Talee

GUDID 00860013898021

Cranial orthosis

Primary Device ID	00860013898021
NIH Device Record Key	4d4742db-3b6d-4acf-8352-fdc8e2c82ca2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Talee
Version Model Number	Talee w/2in1/One-Side Opening
Company DUNS	111474988
Company Name	INVENT MEDICAL USA LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860013898021 [Primary]

MVA	Orthosis, Cranial

Steralize Prior To Use	false
Device Is Sterile	false

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

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