MyCRO Band

GUDID 04064409000104

MyCRO Band w/Lining beige

OTTO BOCK HEALTHCARE

Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis Cranial orthosis
Primary Device ID04064409000104
NIH Device Record Key979892ff-03f9-4b9b-8a9d-8363e24558cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyCRO Band
Version Model Number24H1=9
Company DUNS932133408
Company NameOTTO BOCK HEALTHCARE
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104064409000104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OANOrthosis, Cranial, Laser Scan

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-06
Device Publish Date2021-03-29

On-Brand Devices [MyCRO Band]

04064409000104MyCRO Band w/Lining beige
04064409000098MyCRO Band w/Lining brown
04064409000081MyCRO Band w/Lining black
04064409000074MyCRO Band w/Lining blue
04064409000067MyCRO Band w/Lining green
04064409000050MyCRO Band w/Lining dark red
04064409000043MyCRO Band w/Lining orange
04064409000036MyCRO Band w/Lining pink
04064409000029MyCRO Band w/Lining purple
04064409000012MyCRO Band w/Lining grey

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