FDA.reportPublic FDA data

Talee

Primary DI
00860013898083
Brand
Talee
Company
INVENT MEDICAL USA LLC
Model
Talee w/G1-Bi-Valve Opening
Device 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.
Published
2026-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVAOrthosis, Cranial
OANOrthosis, Cranial, Laser Scan

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVAOrthosis, CranialNeurology2
OANOrthosis, Cranial, Laser ScanNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220681000Talee, Talee PostOPInvent Medical USA, LLC2022-09-22MVA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013898083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013898083008600138980838600138980830860013898083

GMDN Terms#

Term, Definition table
TermDefinition
Cranial orthosisA custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
+1 (267) 368-8165support@inventmedical.com

Regulatory Flags#

DUNS number
111474988
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013898090Talee PostOpTalee PostOp w/G1-Bi-Valve Opening2026-04-28
00860015811103TaleeTalee w/G2-Bi-Valve Opening2026-04-28
00860015811110Talee PostOpTalee PostOp w/G2-Bi-Valve Opening2026-04-28
00860013898007TaleeTalee w/One-Side Opening2025-05-12
00860013898014TaleeTalee w/Bi-Valve Opening2025-05-12
00860013898021TaleeTalee w/2in1/One-Side Opening2025-05-12
00860013898038TaleeTalee w/2in1/Bi-Valve Opening2025-05-12
00860013898045Talee PostOpTalee PostOp w/One-Side Opening2025-05-12
00860013898052Talee PostOpTalee PostOp w/Bi-Valve Opening2025-05-12
00860013898069Talee PostOpTalee PostOp w/2in1/One-Side Opening2025-05-12
00860013898076Talee PostOpTalee PostOp w/2in1/Bi-Valve Opening2025-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859065006041Hanger Cranial BandSymbiont Logistics, LLCMVA2026-05-11
00860013898090Talee PostOpINVENT MEDICAL USA LLCMVA2026-04-28
00860013898090Talee PostOpINVENT MEDICAL USA LLCOAN2026-04-28
00860015811103TaleeINVENT MEDICAL USA LLCMVA2026-04-28
00860015811103TaleeINVENT MEDICAL USA LLCOAN2026-04-28
00860015811110Talee PostOpINVENT MEDICAL USA LLCMVA2026-04-28
00860015811110Talee PostOpINVENT MEDICAL USA LLCOAN2026-04-28
00860013026103Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013026103Doc Band®Cranial Technologies, Inc.OAN2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.OAN2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013898007TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898007TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898014TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898014TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898021TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898021TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898038TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898038TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898045Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898045Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898052Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898052Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898069Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898069Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898076Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898076Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00859065006034Sprout3DSurestep, LLCMVA2025-02-03
00859065006027Hanger Cranial Band 3DSymbiont Logistics, LLCMVA2024-12-26
B15176210A0STARband® 3DORTHOMERICA PRODUCTS, INC.OAN2024-10-17