FDA UDI
In Commercial Distribution
🇺🇸 United States
Spetzler™ Lighted Suction Tube, 9 French, 140mm long
DI: 10817489025045
·
Model: DN1509-140
·
KATALYST SURGICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Spetzler™ Lighted Suction Tube, 9 French, 140mm long
- Primary DI
- 10817489025045
- Version / Model
- DN1509-140
- Company Name
- KATALYST SURGICAL LLC
- Labeler DUNS
- 007883297
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-11-15
- Public Version
- 1
- Public Version Date
- 2020-11-23
- Public Version Status
- New
- Public Device Record Key
- 91ae5df3-299a-433e-9223-85c36802af5b
Device Description
Spetzler™ Lighted Suction Tube, 9 French, 140mm long, box of 5
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FST | Light, Surgical, Fiberoptic | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38518 | Surgical/emergency suction cannula, illuminating, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00817489025048 | GS1 | ||||
| Primary | 10817489025045 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141781 | 000 |