FDA.reportPublic FDA data

MyCRO Band

Primary DI
04064409000050
Brand
MyCRO Band
Company
OTTO BOCK HEALTHCARE
Model
24H1=2.5
Device description
MyCRO Band w/Lining dark red
Published
2021-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K201426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201426000MyCRO BandOtto Bock Healthcare LP2021-03-26MVA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04064409000050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064409000050040644090000504064409000050

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
932133408
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04064409000081MyCRO Band24H1=72021-03-29
04032767811571BiOM T2757B162018-04-11
04032767832859Empower757B382018-04-11
04064409000012MyCRO Band24H1=12021-03-29
04064409000029MyCRO Band24H1=112021-03-29
04064409000036MyCRO Band24H1=122021-03-29
04064409000043MyCRO Band24H1=132021-03-29
04064409000067MyCRO Band24H1=32021-03-29
04064409000074MyCRO Band24H1=52021-03-29
04064409000098MyCRO Band24H1=82021-03-29
04064409000104MyCRO Band24H1=92021-03-29
04064409002634Empower1A1-2=L25-3/152021-03-01
04064409002641Empower1A1-2=L25-3/42021-03-01
04064409002658Empower1A1-2=L25-4/152021-03-01
04064409002665Empower1A1-2=L25-4/42021-03-01
04064409002672Empower1A1-2=L25-5/152021-03-01
04064409002689Empower1A1-2=L25-5/42021-03-01
04064409002696Empower1A1-2=L25-6/152021-03-01
04064409002702Empower1A1-2=L25-6/42021-03-01
04064409002719Empower1A1-2=L26-3/152021-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859065006041Hanger Cranial BandSymbiont Logistics, LLCMVA2026-05-11
00860013898083TaleeINVENT MEDICAL USA LLCMVA2026-04-28
00860013898083TaleeINVENT MEDICAL USA LLCOAN2026-04-28
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 LLCOAN2026-04-28
00860015811110Talee PostOpINVENT MEDICAL USA LLCMVA2026-04-28
00860013026103Doc Band®Cranial Technologies, Inc.OAN2026-03-04
00860013026103Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.OAN2026-03-04
00860013898007TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898007TaleeINVENT MEDICAL USA LLCOAN2025-05-12
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 LLCMVA2025-05-12
00860013898052Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898069Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898069Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898076Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898076Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00859065006034Sprout3DSurestep, LLCMVA2025-02-03