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Speedboat Ultraslim (SB1L) Electrosurgical Instrument

FDA UDIEUDAMED

Class II (US FDA UDI)

by Creo Medical, Ltd.

Identity

Trade Name
Speedboat Ultraslim (SB1L) Electrosurgical Instrument FDA UDI
Generic Name
Endoscopic electrosurgical/microwave submucosal lift/resection instrument FDA UDI
Device Name
Speedboat UltraSlim 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 FDA UDI
Model / Reference
Speedboat Ultraslim Long (SB1L) FDA UDI
Description
Speedboat UltraSlim 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 FDA UDI

Identifiers

Catalog Number
PRD-SB1-001 FDA UDI
Primary DI / UDI-DI
05060359560643 FDA UDI
FDA Product Code
KNS FDA UDI
GMDN Term
Endoscopic electrosurgical/microwave submucosal lift/resection instrument FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 1.9 Meter FDA UDI
Outer Diameter — 2.4 Millimeter FDA UDI

Category: Endoscopic electrosurgical/microwave submucosal lift/resection instrument

Speedboat Ultraslim (SB1L) Electrosurgical Instrument by Creo Medical, Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Endoscopic electrosurgical/microwave submucosal lift/resection instrument.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Creo Medical, Ltd.

Sources (2)

  • FDA UDI 826611af-548a-4f79-920c-8e8c4e4e3883 37 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026