DEMATOSCOPE WITH PROFESSIONAL SW (5X-200x) FEDMEDMICFIPSWD_US

GUDID B1623141

DEMATOSCOPE WITH PROFESSIONAL SW (5X-200x)

BELLEGROVE MEDICAL SUPPLY, INC.

Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct

• Primary Device ID: B1623141
• NIH Device Record Key: f578bd71-7842-422c-ae5b-649b31e70055
• Commercial Distribution Discontinuation: 2022-09-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEMATOSCOPE WITH PROFESSIONAL SW (5X-200x)
• Version Model Number: BTS-314
• Catalog Number: FEDMEDMICFIPSWD_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: true
• 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	B1623141 [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