FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AMD LASERS Bendable Disposable Tips (Assortment of 25)
DI: 00851759007020
·
Model: TIP25
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AMD Lasers
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AMD LASERS Bendable Disposable Tips (Assortment of 25)
- Primary DI
- 00851759007020
- Version / Model
- TIP25
- Catalog Number
- TIP25
- Company Name
- AMD Lasers
- Labeler DUNS
- 080354039
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 4
- Public Version Date
- 2020-11-03
- Public Version Status
- Update
- Public Device Record Key
- a7aa1769-4bbf-4f07-bb18-4ae9187bb30a
- Distribution End Date
- 2020-10-31
Device Description
Bendable disposable tips (assortment of 25 tips) for use with AMD LASERS' Picasso Line of Soft-Tissue Dental Lasers. Contains ten (10) 400um core diameter 5mm length tips, ten (10) 400um core diameter 10mm length tips, and five (5) 300um core diameter 10mm length tips. All tips are pre-bent to 60 degree angle.
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 60340 | Dental diode laser system | A mains electricity (AC-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 oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851759007020 | GS1 |
Customer Contacts
- Phone
- 866-999-2635
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 60 | degree |