FDA UDI
In Commercial Distribution
🇺🇸 United States
ESI
DI: B3964500600
·
Model: 45-0060
·
FTT MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ESI
- Primary DI
- B3964500600
- Version / Model
- 45-0060
- Company Name
- FTT MEDICAL, INC.
- Labeler DUNS
- 002212793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 5
- Public Version Date
- 2020-04-20
- Public Version Status
- Update
- Public Device Record Key
- 68016a5d-f5fc-47a8-9be4-91162a50da3b
Device Description
LIGHT & SUCTION ATTACHMENT FOR CAUTERY PENCIL. ACMI FITTING.
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
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HAM | Apparatus, Electrosurgical | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35528 | Surgical/emergency suction cannula, illuminating, reusable | An atraumatic, invasive, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or clear an airway obstruction, whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic, nor an intravascular device; it is not designed for surgical irrigation. It has a built-in light or fibreoptic bundle used to illuminate the operative site. Often referred to a as suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or tubing. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B3964500600 | HIBCC |