FDA.reportPublic FDA data

Smart Drain Round Coaxial Drain Fr 24

Primary DI
18034139296675
Brand
Smart Drain Round Coaxial Drain Fr 24
Company
REDAX SPA
Model
24727
Catalog number
24727
Device description
A sterile and single-use silicone device characterized by a drainage groove section and a round section portion.
Published
2021-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBPCatheter, Multiple Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBPCatheter, Multiple LumenGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18034139296675PackageGS110In Commercial Distribution
08034139296678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803413929667518034139296675
08034139296678080341392966788034139296678

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainA sterile, tube-like device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a wide variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, and general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp metal trocar, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+17868187337christian.costantini@redax.it

Regulatory Flags#

DUNS number
338664915
Device count
1
DM exempt
false
Premarket exempt
true
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
08034139292809Thoracic Catheter, Straight Fr 1220812208122021-05-04
08034139292816Thoracic Catheter, Straight Fr 1520815208152021-05-05
08034139292823Thoracic Catheter, Straight Fr 1820818208182021-05-07
08034139292830Thoracic Catheter, Straight Fr 2120821208212021-05-07
08034139292847Thoracic Catheter, Straight Fr 2420824208242021-05-07
08034139292854Thoracic Catheter, Straight Fr 2820828208282021-05-05
08034139292861Thoracic Catheter, Straight Fr 3020830208302021-05-07
08034139292878Thoracic Catheter, Straight Fr 3320833208332021-05-07
08034139292885Thoracic Catheter, Straight Fr 3620836208362021-05-05
08034139293783Thoracic Catheter, Angled Fr 2421824218242021-05-05
08034139293790Thoracic Catheter, Angled Fr 2821828218282021-05-05
08034139293806Thoracic Catheter, Angled Fr 3021830218302021-05-07
08034139293813Thoracic Catheter, Angled Fr 3321833218332021-05-07
08034139293820Thoracic Catheter, Angled Fr 3621836218362021-05-05
08034139290874Drentech Pump 100 ml Round Drainage w/trocar Fr 1510483104832021-05-04
08034139294506Flat Drain type Jackson-Pratt 3x7 mm24100241002021-05-03
08034139294513Flat Drain 3/4 type Jackson-Pratt 3x7 mm w/trocar24101241012021-05-05
08034139294520Flat Drain type Jackson-Pratt 3x7 mm24110241102021-05-05
08034139294537Flat Drain type Jackson-Pratt 3x7 mm w/trocar24111241112021-05-05
08034139294544Flat Drain 3/4 type Jackson-Pratt 4x10 mm24120241202021-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14710961934766Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-12-15
14710961934773Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-12-15
14710961934780Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-12-15
04710961934769Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-12-15
04710961934776Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-12-15
04710961934783Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-12-15
14710961934759Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-11-22
04710961934752Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-11-22
08034139296494Smart Drain Round Coaxial Drain Fr 28REDAX SPAGBP2021-05-07
08034139296517Smart Drain Round Coaxial Drain Fr 24REDAX SPAGBP2021-05-07
08034139296678Smart Drain Round Coaxial Drain Fr 24REDAX SPAGBP2021-05-07
08034139296685Smart Drain Round Coaxial Drain Fr 28REDAX SPAGBP2021-05-07
08034139297309Smart Drain Round Coaxial Drain Fr 28REDAX SPAGBP2021-05-07
18034139296491Smart Drain Round Coaxial Drain Fr 28REDAX SPAGBP2021-05-07
18034139296514Smart Drain Round Coaxial Drain Fr 24REDAX SPAGBP2021-05-07
18034139296682Smart Drain Round Coaxial Drain Fr 28REDAX SPAGBP2021-05-07
18034139297306Smart Drain Round Coaxial Drain Fr 28REDAX SPAGBP2021-05-07
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