Primary Device ID | D8199013862 |
NIH Device Record Key | 32d42563-58df-45c8-8089-52b8a44fa8fe |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pedo OnBrace Crown LR7 (5/pk) |
Version Model Number | 901386 |
Company DUNS | 106645484 |
Company Name | SPECIALTY APPLIANCES, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |