Talee PostOp

GUDID 00860013898045

The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.

INVENT MEDICAL USA LLC

Cranial orthosis
Primary Device ID00860013898045
NIH Device Record Key57e885af-3cff-4139-ac58-7b0e746b434f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTalee PostOp
Version Model NumberTalee PostOp w/One-Side 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
GS100860013898045 [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 PostOp]

00860013898076The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgic
00860013898069The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgic
00860013898052The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgic
00860013898045The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgic

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