| Primary Device ID | D930145080050 |
| NIH Device Record Key | bc21730f-e384-41e5-aca1-f9e7fa60bafb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JMU |
| Version Model Number | 14508005 |
| Company DUNS | 081258380 |
| Company Name | JMU DENTAL, 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D930145080050 [Primary] |
| EJL | Bur, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
[D930145080050]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-29 |
| Device Publish Date | 2024-03-21 |
| D930253010040 | Gloves, Nitrile,3.5mil, Size XL, Pale Violet, 100pcs/Box |
| D930253010080 | JMU Disposable Nitrile Exam Gloves, Powder-free, Non-Sterile, Ambidextrous, Size XL, Blue, 100pc |
| D930253010070 | JMU Disposable Nitrile Exam Gloves, Powder-free, Non-Sterile, Ambidextrous, Size L, Blue, 100pcs |
| D930253010060 | JMU Disposable Nitrile Exam Gloves, Powder-free, Non-Sterile, Ambidextrous, Size M, Blue, 100pcs |
| D930253010050 | JMU Disposable Nitrile Exam Gloves, Powder-free, Non-Sterile, Ambidextrous, Size S, Blue, 100pcs |
| D930253010120 | JMU Nitrile Examination Gloves, 3.9+/-0.3g, Size XL, Powder-Free, Non-Sterile, Blue, 200pcs/box |
| D930253010110 | JMU Nitrile Examination Gloves, 3.3+/-0.3g, Size L, Powder-Free, Non-Sterile, Blue, 200pcs/box |
| D930253010100 | JMU Nitrile Examination Gloves, 3.0+/-0.3g, Size M, Powder-Free, Non-Sterile, Blue, 200pcs/box |
| D930253010090 | JMU Nitrile Examination Gloves, 2.7g+/-0.3g, Size S, Powder-Free, Non-Sterile, Blue, 200pcs/box |
| D930253010130 | JMU Nitrile Examination Gloves, 2.5+/-0.3g, Size XS, Powder-Free, Non-Sterile, Blue, 200pcs/box |
| D930253010210 | JMU M3.0g Disposable Nitrile Examination Gloves, Size L, Finger Texture, Powder Free, Non-steril |
| D930253010200 | JMU M3.0g Disposable Nitrile Examination Gloves, Size M, Finger Texture, Powder Free, Non-steril |
| D930253010190 | JMU M3.0g Disposable Nitrile Examination Gloves, Size S, Finger Texture, Powder Free, Non-steril |
| D930253010180 | JMU M3.0g Disposable Nitrile Examination Gloves, Size XS, Finger Texture, Powder Free, Non-steri |
| D930253010270 | JMU M3.0g Nitrile Examination Gloves, Size XL, Powder-Free, Non-Sterile, Black, 200pcs/box |
| D930253010260 | JMU M3.0g Nitrile Examination Gloves, Size L, Powder-Free, Non-Sterile, Black, 200pcs/box |
| D930253010250 | JMU M3.0g Nitrile Examination Gloves, Size M, Powder-Free, Non-Sterile, Black, 200pcs/box |
| D930253010240 | JMU M3.0g Nitrile Examination Gloves, Size S, Powder-Free, Non-Sterile, Black, 200pcs/box |
| D930253010230 | JMU M3.0g Nitrile Examination Gloves, Size XS, Powder-Free, Non-Sterile, Black, 200pcs/box |
| D930321160120 | Autoclave Sterilization Wrap Sheets (CSR), 60gsm SMMS Non-Woven, 36"x36", blue, 50pcs/bag, 250pc |
| D930321160110 | Autoclave Sterilization Wrap Sheets (CSR), 60gsm SMMS Non-Woven, 30"x30", blue, 50pcs/bag, 250pc |
| D930321160100 | Autoclave Sterilization Wrap Sheets (CSR), 60gsm SMMS Non-Woven, 24"x24", blue, 50pcs/bag, 500pc |
| D930321160090 | Autoclave Sterilization Wrap Sheets (CSR), 60gsm SMMS Non-Woven, 18"x18", blue, 50pcs/bag, 500pc |
| D930321160080 | Autoclave Sterilization Wrap Sheets (CSR), crepe paper, 60grams, 18"x18", blue, 100pcs/bag, 1000 |
| D930321160070 | Autoclave Sterilization Wrap Sheets (CSR), crepe paper, 60grams, 12"x12", blue, 100pcs/bag, 1000 |
| D930253010440 | JMU M3.5g Premium Nitrile Examination Gloves, Size XL, Powder-Free, Non-Sterile, Violet Blue, 20 |
| D930253010430 | JMU M3.5g Premium Nitrile Examination Gloves, Size L, Powder-Free, Non-Sterile, Violet Blue, 200 |
| D930253010420 | JMU M3.5g Premium Nitrile Examination Gloves, Size M, Powder-Free, Non-Sterile, Violet Blue, 200 |
| D930253010410 | JMU M3.5g Premium Nitrile Examination Gloves, Size S, Powder-Free, Non-Sterile, Violet Blue, 200 |
| D930253010400 | JMU M3.5g Premium Nitrile Examination Gloves, Size XS, Powder-Free, Non-Sterile, Violet Blue, 20 |
| D930253010280 | JMU M3.5g Premium Nitrile Examination Gloves, Size XS, Aloe Coasted, Powder-Free, Non-Sterile, P |
| D930253020080 | JMU M5.5g Premium Latex Examination Gloves, Size XL, Polymer Coasted, Powder-free, Non-Sterile, |
| D930253020070 | JMU M5.5g Premium Latex Examination Gloves, Size L, Polymer Coasted, Powder-free, Non-Sterile, W |
| D930253020060 | JMU M5.5g Premium Latex Examination Gloves, Size M, Polymer Coasted, Powder-free, Non-Sterile, W |
| D930253020050 | JMU M5.5g Premium Latex Examination Gloves, Size S, Polymer Coasted, Powder-free, Non-Sterile, W |
| D930253020040 | JMU M5.5g Premium Latex Examination Gloves, Size XS, Polymer Coasted, Powder-free, Non-Sterile, |
| D930253010320 | JMU M3.5g Premium Nitrile Examination Gloves, Size XL, Aloe Coasted, Powder-Free, Non-Sterile, P |
| D930253010310 | JMU M3.5g Premium Nitrile Examination Gloves, Size L, Aloe Coasted, Powder-Free, Non-Sterile, Pi |
| D930253010300 | JMU M3.5g Premium Nitrile Examination Gloves, Size M, Aloe Coasted, Powder-Free, Non-Sterile, Pi |
| D930253010290 | JMU M3.5g Premium Nitrile Examination Gloves, Size S, Aloe Coasted, Powder-Free, Non-Sterile, Pi |
| D930145080090 | JMU Surgical Carbide Burs, Straight Fissure Crosscut, FG SURG #558, 5/pk (ISO No. 107/012) |
| D930145080080 | JMU Surgical Carbide Burs, Straight Fissure Crosscut, FG SURG #557, 5/pk (ISO No. 107/010) |
| D930145080070 | JMU Surgical Carbide Burs, Taper Fissure Crosscut, FG SURG #702, 5/pk (ISO No. 168/016) |
| D930145080060 | JMU Surgical Carbide Burs, Taper Fissure Crosscut, FG SURG #701, 5/pk (ISO No. 168/012) |
| D930145080050 | JMU Surgical Carbide Burs, Taper Fissure Crosscut, FG SURG #700, 5/pk (ISO No. 168/010) |
| D930145080040 | JMU Surgical Carbide Burs, Round, FG SURG #8, 5/pk (ISO No. 001/023) |
| D930145080030 | JMU Surgical Carbide Burs, Round, FG SURG #6, 5/pk (ISO No. 001/018) |
| D930145080020 | JMU Surgical Carbide Burs, Round, FG SURG #4, 5/pk (ISO No. 001/014) |
| D930145080010 | JMU Surgical Carbide Burs, Round, FG SURG #2, 5/pk (ISO No. 001/010) |
| D930145030040 | JMU Surgical Carbide Burs, Round, RA SURG #6, 5/pk (ISO No. 001/018) |