Primary Device ID | 04064409000036 |
NIH Device Record Key | 6dedc1e2-fbbd-45c5-9fe0-2af2f81776d8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MyCRO Band |
Version Model Number | 24H1=12 |
Company DUNS | 932133408 |
Company Name | OTTO BOCK HEALTHCARE |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04064409000036 [Primary] |
MVA | Orthosis, Cranial |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-04-06 |
Device Publish Date | 2021-03-29 |
04064409000104 | MyCRO Band w/Lining beige |
04064409000098 | MyCRO Band w/Lining brown |
04064409000081 | MyCRO Band w/Lining black |
04064409000074 | MyCRO Band w/Lining blue |
04064409000067 | MyCRO Band w/Lining green |
04064409000050 | MyCRO Band w/Lining dark red |
04064409000043 | MyCRO Band w/Lining orange |
04064409000036 | MyCRO Band w/Lining pink |
04064409000029 | MyCRO Band w/Lining purple |
04064409000012 | MyCRO Band w/Lining grey |