Primary Device ID | B1621071 |
NIH Device Record Key | f95fe46c-3e33-4899-b525-d3a2ea8077e6 |
Commercial Distribution Discontinuation | 2022-09-30 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | WI-FI OTOSCOPE |
Version Model Number | BTS-306 |
Company DUNS | 141647094 |
Company Name | BELLEGROVE MEDICAL SUPPLY, INC. |
Device Count | 1 |
DM Exempt | true |
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 | 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 | true |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B1621071 [Primary] |
ERA | Otoscope |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-08-26 |
Device Publish Date | 2021-08-18 |
B1621250 - N.100 SPECULUM 7.0MM | 2021-10-20 N.100 SPECULUM 7.0MM |
B1623241 - N.100 SPECULUM 6.0MM | 2021-10-20 N.100 SPECULUM 6.0MM |
B1623261 - CONTACT CAP H=30MM CAMPATIBLE WITH FEDMEDMICFIP/5M | 2021-10-20 CONTACT CAP H=30MM CAMPATIBLE WITH FEDMEDMICFIP/5M |
B1623271 - CLOSED CAP FOR FEDMEDMICFIP/P5M/UVW/UVWP/STD | 2021-10-20 CLOSED CAP FOR FEDMEDMICFIP/P5M/UVW/UVWP/STD |
B1623211 - N.100 SPECULUM 3.5MM | 2021-10-19 N.100 SPECULUM 3.5MM |
B1623221 - N.100 SPECULUM 4.3MM | 2021-10-19 N.100 SPECULUM 4.3MM |
B1623231 - N.100 SPECULUM 5.0MM | 2021-10-19 N.100 SPECULUM 5.0MM |
B1623001 - DERMATOCOPE - POLARIZED FILTER | 2021-10-05 DERMATOCOPE - POLARIZED FILTER |