FDA.report

FlowTube HF-C

Primary DI
04048223006894
Brand
FlowTube HF-C
Company
Pajunk GmbH Medizintechnologie
Model
1299-01-15
Catalog number
1299-01-15
Device description
FlowTube HF-C Adaptable Knife Electrode with ceramic tip, monopolar
Published
2020-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048223006894PrimaryGS10
04048223083673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048223006894040482230068944048223006894
04048223083673040482230836734048223083673

GMDN Terms

TermDefinition
Haemostatic knifeA hand-operated surgical instrument, similar in appearance to a surgical scalpel, designed for simultaneous cutting of tissues and cauterization (haemostasis) of blood vessels by applying an electrically-heated blade. It typically consists of a high-resistance, flat, sharp blade at the distal end and a handle at the proximal end with an electric cable; the blade is typically an integral part of the knife. Haemostasis is induced by direct transmission of thermal energy (heat) from the blade to the tissues; negating the use of grounding electrodes. It is used for a variety of procedures, including general and plastic surgery, gynaecology, and orthopaedics. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(888)972-5865info@pajunk-usa.com
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags

DUNS number
317654283
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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