FDA UDI
In Commercial Distribution
🇺🇸 United States
Diode Laser Tips
DI: 00647529003640
·
Model: Surgical EZ Tips
·
Biolase, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diode Laser Tips
- Primary DI
- 00647529003640
- Version / Model
- Surgical EZ Tips
- Catalog Number
- 7400053
- Company Name
- Biolase, Inc.
- Labeler DUNS
- 152165700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-17
- Public Version
- 6
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- d99f9294-f209-43f5-b8bd-ad8ea9b61aff
Device Description
A tip kit containing 3 single-use laser tips intended for use with Epic S-Series laser systems. The tips have the same core diameter of 400 microns and vary in length.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60341 | General/multiple surgical diode laser system | An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00647529003640 | GS1 |
Customer Contacts
- Phone
- 1-800-321-6717
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130465 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 400 | Micrometer | |
| Length | 250 | Millimeter | |
| Length | 100 | Millimeter |