FDA UDI
In Commercial Distribution
🇺🇸 United States
FiberLase
DI: 00860009714922
·
Model: AC-1059640
·
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- FiberLase
- Primary DI
- 00860009714922
- Version / Model
- AC-1059640
- Company Name
- TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
- Labeler DUNS
- 130213366
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-06-20
- Public Version
- 7
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 1453f069-ff4f-46ba-87ce-b51a2ac372fc
Device Description
Cleaning Kit for FiberLase GYN Lap Handpieces
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 61474 | General/multiple surgical laser system beam guide, reusable | A 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; a fibreoptic cable may be included with the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009714922 | GS1 | ||||
| Unit of Use | 10860009714929 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K952006 | 000 |