| Primary Device ID | 00647529004647 |
| NIH Device Record Key | 8c0806c3-226c-44cb-aeeb-bcfe20d2144c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Diode Laser Tips |
| Version Model Number | Epic Q, surgical assortment kit, 30PK |
| Catalog Number | 6400258 |
| Company DUNS | 152165700 |
| Company Name | Biolase, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-321-6717 |
| Diodeservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Diodeservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Diodeservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Diodeservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Diodeservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Diodeservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Diodeservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Diodeservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Diodeservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Diodeservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Diodeservice@biolase.com |
| Length | 4 Millimeter |
| Outer Diameter | 400 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 300 Micrometer |
| Length | 4 Millimeter |
| Outer Diameter | 400 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 300 Micrometer |
| Length | 4 Millimeter |
| Outer Diameter | 400 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 300 Micrometer |
| Length | 4 Millimeter |
| Outer Diameter | 400 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 300 Micrometer |
| Length | 4 Millimeter |
| Outer Diameter | 400 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 300 Micrometer |
| Length | 4 Millimeter |
| Outer Diameter | 400 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 300 Micrometer |
| Length | 4 Millimeter |
| Outer Diameter | 400 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 300 Micrometer |
| Length | 4 Millimeter |
| Outer Diameter | 400 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 300 Micrometer |
| Length | 4 Millimeter |
| Outer Diameter | 400 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 300 Micrometer |
| Length | 4 Millimeter |
| Outer Diameter | 400 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 300 Micrometer |
| Length | 4 Millimeter |
| Outer Diameter | 400 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 300 Micrometer |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00647529004647 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00647529004647]
Moist Heat or Steam Sterilization
[00647529004647]
Moist Heat or Steam Sterilization
[00647529004647]
Moist Heat or Steam Sterilization
[00647529004647]
Moist Heat or Steam Sterilization
[00647529004647]
Moist Heat or Steam Sterilization
[00647529004647]
Moist Heat or Steam Sterilization
[00647529004647]
Moist Heat or Steam Sterilization
[00647529004647]
Moist Heat or Steam Sterilization
[00647529004647]
Moist Heat or Steam Sterilization
[00647529004647]
Moist Heat or Steam Sterilization
[00647529004647]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-07 |
| Device Publish Date | 2024-04-29 |
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| 00647529003398 | A single-use fiberoptic pre-initiated tip intended for use with diode laser systems. |
| 00647529003381 | A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser |
| 00647529003374 | A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser |
| 00647529003367 | A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser |
| 00647529003350 | A single-use fiberoptic pre-initiated tip intended for use with diode laser systems. |
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| 00647529003206 | A single-use fiberoptic pre-initiated tip intended for use with Epic Pro diode laser systems. |
| 00647529001967 | An assortment kit containing 30 single-use pre-initiated tips intended for use with diode laser |
| 00647529001851 | A tip kit containing 2 single-use laser tips intended for use with Epic S-Series laser systems. |
| 00647529001820 | A tip kit containing 30 single-use laser tips intended for use with Biolase diode laser systems. |
| 00647529001813 | A tip kit containing 30 single-use laser tips intended for use with diode laser systems. The tip |
| 00647529001943 | A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser |
| 00647529001912 | A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser |
| 00647529001929 | A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser |
| 00647529001936 | A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser |
| 00647529000441 | A single-use non-sterile fiberoptic pre-initiated tip intended for use with Biolase diode laser |
| 00647529001899 | A single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems. |
| 00647529001882 | A single-use fiberoptic accessory intended for use with Epic surgical diode laser systems. |
| 00647529001875 | A single-use fiberoptic accessory intended for use with Epic surgical diode laser systems. |
| 00647529001868 | A non-sterile single-use laser tip intended for use with Epic surgical diode laser systems such |
| 00647529001837 | A non-sterile, single-use fiberoptic laser tip intended for use with Biolase diode laser systems |
| 00647529002643 | A single-use non-sterile fiberoptic laser tip intended for use with Biolase diode laser systems. |
| 00647529000359 | A single-use fiberoptic laser tip intended for use with Biolase diode laser systems. |
| 00647529001806 | A single-use fiberoptic laser tip intended for use with Biolase diode laser systems. |
| 00647529001790 | A non-sterile, single-use fiberoptic laser tip intended for use with Biolase diode laser systems |
| 00647529001783 | A single-use fiberoptic laser tip intended for use with Biolase diode laser systems. |
| 00647529000311 | A non-sterile, single-use fiberoptic tip accessory intended for use with Biolase diode laser sys |
| 00647529004005 | An assortment kit containing a combination of uninitiated and pre-initiated laser tips intended |
| 00647529001844 | An assortment kit composed of thirty single-use fiberoptic laser tip intended for use with Biola |
| 00647529000137 | A single-use fiberoptic laser tip intended for use with Biolase diode laser systems. |
| 00647529000120 | A single-use fiberoptic laser tip intended for use with Biolase diode laser systems. |
| 00647529004647 | An assortment kit composed of thirty single-use fiberoptic laser tip intended for use with Biola |