FDA.reportPublic FDA data

Sprout3D

Primary DI
00859065006034
Brand
Sprout3D
Company
Surestep, LLC
Model
A8210
Device description
Cranial Remolding Orthosis
Published
2025-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MVAOrthosis, Cranial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVAOrthosis, CranialNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859065006034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859065006034008590650060348590650060340859065006034

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
831515585
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013026103Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013898007TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898014TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898021TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898038TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898045Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898052Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898069Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898076Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00859065006027Hanger Cranial Band 3DSymbiont Logistics, LLCMVA2024-12-26
B15176210A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
B15176310A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
B15176410A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
B15176510A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
B15176610A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
00196852667895P-PODPPOD Orthotics Inc.MVA2023-11-20
00860010708101Boston BandBoston Orthotics & ProstheticsMVA2023-09-13
B15170309A0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170309PA0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170409A0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170409PA0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170909A0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170909PA0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170910A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15176009A0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15176009PA0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15176109A0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15176109PA0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15176209A0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29