FDA.reportPublic FDA data

Speedboat Ultraslim (SB1L) Electrosurgical Instrument

Primary DI
05060359560650
Brand
Speedboat Ultraslim (SB1L) Electrosurgical Instrument
Company
CREO MEDICAL LIMITED
Model
Speedboat Ultraslim Long (SB1L)
Catalog number
PRD-SB1-001
Device 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
Published
2023-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060359560636PackageGS15In Commercial Distribution
05060359560650PackageGS11In Commercial Distribution
05060359560643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060359560636050603595606365060359560636
05060359560650050603595606505060359560650
05060359560643050603595606435060359560643

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic microwave ablation probe/needleA flexible, invasive, hand-held endoscopic device assembly intended to deliver microwave energy to tissues for coagulation, whilst allowing injection of a solution (e.g., vasoconstrictive agents) primarily to help control/stop serious bleeds (haemostasis) during endoscopic surgery. It includes a microwave antenna, a port with a distal needle, and proximal handpiece with controls for needle retraction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.9Meter
Outer Diameter2.4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure69 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure69 KiloPascal109 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18662261170uscustomerservice@creomedical.com

Regulatory Flags#

DUNS number
733853373
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060359560100Footswitch7-PG1-1327-PG1-1322026-04-17
05060359560209MicroBlate Flex7-AB1-0012021-07-29
05060359560513Croma Generator7-EMR-050 V6.017-EMR-0502024-01-09
05060359560575Speedboat RS2 8 Fr Instrument7-RS2-0037-RS2-0032023-11-08
05060359560643Speedboat Ultraslim LongPRD-SB1-001PRD-SB1-0012023-12-06
05060359561183CROMA Electrosurgical Generator7-EMR-050 V6.0017-EMR-0502024-10-08
05060359560292CROMA Electrosurgical Generator7-EMR-050 V4.02021-03-15
05060359560223SlypSeal Flex7-HS1-0017-HS1-0012020-12-31
05060359560070Interface Cable, single use, 1.5 m2-RS2-2102-RS2-2102020-11-23
05060359560025Speedboat Inject 10 Fr7-RS2-0017-RS2-0012018-11-14
05060359560063Procedure Pack Interface Cable, single use, 1.5 m7-RS2-210 7-RS2-2102018-11-15
05060359560087CROMA Electrosurgical Generator with Footswitch7-EMR-050 2018-11-15
05060359560124CROMA Electrosurgical Generator7-EMR-050 V3.07-EMR-0502019-03-20
05060359560674Speedboat UltraSlim ShortPRD-SB1-002PRD-SB1-0022025-10-03
05060359561329Speedboat Notch ShortPRD-SB1-004PRD-SB1-0042025-10-03
05060359560438SpydrBlade FlexPRD-RG1-001PRD-RG1-0012025-06-12
05060359560971MicroBlate Fine7-NP1-1007-NP1-1002025-05-05
05060359560490MicroBlate Fine7-NP1-1007-NP1-1002025-05-05
05060359561077Speedboat Notch LongPRD-SB1-003PRD-SB1-0032025-03-26
05060359561206CROMA Electrosurgical GeneratorPRD-EMR-050PRD-EMR-0502025-02-10

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