N.100 SPECULUM 5.0MM FEDMEDSP5,0_US

GUDID B1623231

N.100 SPECULUM 5.0MM

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: B1623231
• NIH Device Record Key: 90b94e39-a487-4acc-b22c-fddd2bdc89eb
• Commercial Distribution Discontinuation: 2022-09-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N.100 SPECULUM 5.0MM
• Version Model Number: BTS-323
• Catalog Number: FEDMEDSP5,0_US
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B1623231 [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: 2021-10-19
• Device Publish Date: 2021-10-11

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• 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: 2021-10-19N.100 SPECULUM 5.0MM
• B1623231 - N.100 SPECULUM 5.0MM: 2021-10-19 N.100 SPECULUM 5.0MM
• B1623001 - DERMATOCOPE - POLARIZED FILTER: 2021-10-05 DERMATOCOPE - POLARIZED FILTER