FDA UDI
In Commercial Distribution
🇺🇸 United States
HM-365A-L-DT-FB
DI: 00851272007101
·
Model: HM-365A-L-DT-FB
·
INTERNATIONAL MEDICAL LASERS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HM-365A-L-DT-FB
- Primary DI
- 00851272007101
- Version / Model
- HM-365A-L-DT-FB
- Company Name
- INTERNATIONAL MEDICAL LASERS, INC.
- Labeler DUNS
- 078534357
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 5
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 84e83c76-5d3c-459d-9191-4cb6d4029b29
Device Description
Surgical Laser Fiber 365/400/580 4m fiber, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use, blue extension sleeves with logo, EO sterile, Dome Tip, IML label
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00851272007101 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 286 Degrees Fahrenheit