FDA UDI
In Commercial Distribution
🇺🇸 United States
Diode Laser Tips
DI: 00647529001813
·
Model: Perio EZ Tips Combo Pack, E4
·
Biolase, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diode Laser Tips
- Primary DI
- 00647529001813
- Version / Model
- Perio EZ Tips Combo Pack, E4
- Catalog Number
- 7400019
- Company Name
- Biolase, Inc.
- Labeler DUNS
- 152165700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-11
- Public Version
- 7
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- ec5d6cf1-702c-4896-8003-d50b2fdab862
Device Description
A tip kit containing 30 single-use laser tips intended for use with diode 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 |
|---|---|---|---|---|
| 63476 | General/multiple surgical laser system beam guide, single-use, non-sterile | A non-sterile, surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00647529001813 | GS1 |
Customer Contacts
- Phone
- 1-800-321-6717
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121286 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 9 | Millimeter | |
| Length | 7 | Millimeter | |
| Outer Diameter | 400 | Micrometer |