FDA UDI
In Commercial Distribution
🇺🇸 United States
Taiwan Surgical
DI: 04717480900428
·
Model: TSI-545
·
TAIWAN SURGICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Taiwan Surgical
- Primary DI
- 04717480900428
- Version / Model
- TSI-545
- Company Name
- TAIWAN SURGICAL CORPORATION
- Labeler DUNS
- 657134172
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-07
- Public Version
- 3
- Public Version Date
- 2024-12-09
- Public Version Status
- Update
- Public Device Record Key
- 9d759d85-9c39-478a-8bea-2f5ec322e2fc
Device Description
5mm x 45cm Stainless Steel probe, 290cm Soft Tube
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64120 | Surgical irrigation/aspiration cannula, non-illuminating, single-use | An atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (typically laparoscopy), usually to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04717480900428 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150253 | 000 |