FDA UDI
In Commercial Distribution
🇺🇸 United States
Speedboat UltraSlim Short
DI: 05060359560674
·
Model: PRD-SB1-002
·
CREO MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Speedboat UltraSlim Short
- Primary DI
- 05060359560674
- Version / Model
- PRD-SB1-002
- Catalog Number
- PRD-SB1-002
- Company Name
- CREO MEDICAL LIMITED
- Labeler DUNS
- 733853373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-03
- Public Version
- 1
- Public Version Date
- 2025-10-13
- Public Version Status
- New
- Public Device Record Key
- 5da149e9-22ab-4a2a-9361-33936efa16aa
Device Description
Speedboat is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63397 | Endoscopic electrosurgical/microwave submucosal lift/resection instrument | A flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a lift solution delivery needle or lumen, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060359560681 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 05060359560674 | GS1 | ||||
| Package | 05060359560667 | GS1 | Shipper 5-UP | 5 | In Commercial Distribution | |
| Package | 05060359561268 | GS1 | Shipper 1-UP | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +18662261170
- [email protected]
- Phone
- +441291637300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230328 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1.25 | Meter | |
| Outer Diameter | 2.4 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 69 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 69 – 109 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius