| Primary Device ID | 00849771051619 |
| NIH Device Record Key | 09d4cd25-e03f-4a33-acc0-c58b2f6e3be3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Key Surgical Endoscope Brushes |
| Version Model Number | BR3320 |
| Catalog Number | BR3320 |
| Company DUNS | 604056226 |
| Company Name | KEY SURGICAL, INC. |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849771028666 [Previous] |
| GS1 | 00849771051619 [Primary] |
| MNL | ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00849771051619]
Moist Heat or Steam Sterilization
[00849771051619]
Moist Heat or Steam Sterilization
[00849771051619]
Moist Heat or Steam Sterilization
[00849771051619]
Moist Heat or Steam Sterilization
[00849771051619]
Moist Heat or Steam Sterilization
[00849771051619]
Moist Heat or Steam Sterilization
[00849771051619]
Moist Heat or Steam Sterilization
[00849771051619]
Moist Heat or Steam Sterilization
[00849771051619]
Moist Heat or Steam Sterilization
[00849771051619]
Moist Heat or Steam Sterilization
[00849771051619]
Moist Heat or Steam Sterilization
[00849771051619]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-01 |
| Device Publish Date | 2024-03-22 |
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| 10849771040641 | Endoscope Brush, Double-Ended, Pipe Cleaner, 2300mm L, 5mm Diam, 125mm BAL, 5mm Diam, 20mm BAL |
| 10849771040627 | Endoscope Brush, Double-Action Brush with Squeegee, 2500mm L, 5mm Diam, 20mm BAL |
| 10849771040603 | Endoscope Brush, Brush Kit, Colonoscope, Triple-Cleaning + Channel Brushes |
| 10849771040580 | Endoscope Brush, Brush Kit, Gastroscope, Double-Ended + Channel Brushes |
| 10849771040566 | Endoscope Brush, Brush Kit, Colonoscope, Double-Ended + Channel Brushes |
| 10849771040542 | Endoscope Brush, Triple-Cleaning, 2500mm L, 6mm Diam, 20mm BAL |
| 10849771040528 | Endoscope Brush, Channel Brush, 10mm Diam, 30mm BAL, 5mm Diam, 20mm BAL |
| 10849771040504 | Endoscope Brush, Double-Ended with Handle, 2300mm L, 10mm Diam, 40mm BAL, 5mm Diam, 20mm BAL |
| 10849771041020 | Endoscope Brush, Channel Brush with Handle, 1200mm L, 2mm Diam, 10mm BAL |
| 10849771041013 | Endoscope Brush, Double-Ended, 2500mm L, 6mm Diam, 20mm BAL |
| 10849771041006 | Endoscope Brush, Double-Ended, 1200mm L, 3mm Diam, 20mm BAL |
| 10849771040993 | Endoscope Brush, Double-Ended, 2500mm L, 3mm Diam, 20mm BAL |
| 00849771046226 | Dry Endoscopy Sponge, 2" OD x 0.50" ID x 3.75" Long |
| 00849771046189 | Specialty Cleaning Brushes, Delicate pull-thru, Nylon bristles, S.S., 3mm |
| 00849771046196 | Specialty Cleaning Brushes, Delicate pull-thru, Nylon bristles, S.S., 3mm |
| 00849771046172 | Specialty Cleaning Brushes, nylon both ends(3 &6mm, plastic tube, 230cm |
| 00849771029335 | Scope Cleaning Brush |
| 00849771046219 | Disposable Scope Brush |
| 00849771029243 | Endoscope Brush |
| 00849771029236 | Endoscope Brush |
| 00849771029212 | Endoscope Brush |
| 00849771046202 | Scope Cleaning Brush. 240cmX4-6mm, coated tip |
| 00849771028703 | Scope Brush, ss twisted wire, plastic loop, bead tip, 95cmx2.4mm |
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| 00849771028680 | Specialty Cleaning Brushes, Nylon bristles on both ends of rigid plastic tubing, 3-5 mm tapered |
| 00849771046158 | Specialty Cleaning Brushes, Nylon bristles on both ends, rigid plastic tubing, 3-5 mm tapered di |
| 00849771028666 | Specialty Cleaning Brushes, Nylon bristles on both ends, rigid plastic tubing, 3-5 mm tapered di |
| 00849771046141 | Specialty Cleaning Brushes, Nylon bristles on rigid plastic tubing, 3-5 mm tapered diameter, 2 c |
| 00849771028642 | Specialty Cleaning Brushes, Nylon bristles on rigid plastic tubing, 3-5 mm tapered diameter, 2 c |
| 00849771046134 | Nylon bristles on rigid plastic tubing, 3-5 mm tapered dia, 1 cm brush |
| 00849771028628 | Nylon bristles on rigid plastic tubing, 3-5 mm tapered dia, 1 cm brush |
| 00849771028611 | Specialty Cleaning Brushes, nylon, ss spring coil wire, 3-5mm tapered, bead |
| 00849771028604 | Specialty Cleaning Brushes, nylon, ss spring coil wire, 4-6mm tapered, bead |
| 00849771046127 | Specialty Cleaning Brushes, nylon, rigid plastic tube, 3-5mm tapered |
| 00849771028581 | Specialty Cleaning Brushes, nylon, rigid plastic tube, 3-5mm tapered |
| 00849771046103 | Suction Well Brush, single ended, 3.5" x .433", nylon bristles |
| 00849771022282 | Stainless twisted wire, Beaded tip, 165cm x 2.4mm, 5mm bristle area |
| 00849771022275 | Spring coil w/plastic loop handle, Beaded tip, 95cm x 6mm, 5mm bristle area |
| 00849771022268 | Specialty Cleaning Brushes, Delicate pull-thru, Nylon bristles, S.S., 3mm |
| 00849771022251 | Specialty Cleaning Brushes, Delicate pull-thru, Nylon bristles, S.S., 3mm |
| 00849771046165 | Specialty Cleaning Brushes, Nylon bristles on both ends of rigid plastic tubing, 3-5 mm tapered |
| 00849771022237 | Specialty Brushes, Nylon bristles, Finger loop scope brush, 10.3mm x 11cm |
| 00849771046110 | Double Ended Valve Brush with Nylon bristles, SS & Blue Plastic handle, 4.3mm & 11mm diam, 6" lo |
| 00849771046097 | Specialty Cleaning Brushes, Delicate pull-thru, Nylon bristles, S.S., .078" |
| 00849771022176 | Specialty Cleaning Brushes, Delicate pull-thru, Nylon bristles, S.S., .078" |
| 00849771046080 | Delicate pull-thru brush, Nylon bristles, Stainless steel, 230cm x 1.1mm |
| 00849771022152 | Delicate pull-thru brush, Nylon bristles, Stainless steel, 230cm x 1.1mm |
| 00849771046073 | Specialty Cleaning Brushes, Delicate pull-thru, Nylon bristles, S.S., .045" |