OTOSCOPE FEDMEDMICFIOT_US

GUDID B1623061

OTOSCOPE

BELLEGROVE MEDICAL SUPPLY, INC.

Otoscope, direct

• Primary Device ID: B1623061
• NIH Device Record Key: 8520af0f-badb-44b8-98fe-c519ee0b3afc
• Commercial Distribution Discontinuation: 2022-09-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTOSCOPE
• Version Model Number: BTS-306
• Catalog Number: FEDMEDMICFIOT_US
• Company DUNS: 141647094
• Company Name: BELLEGROVE MEDICAL SUPPLY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B1623061 [Primary]

FDA Product Code

• ERA: Otoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-05
• Device Publish Date: 2021-09-27

Devices Manufactured by BELLEGROVE MEDICAL SUPPLY, INC.

• 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