FDA.reportPublic FDA data

Round Drain type Jackson-Pratt Fr 19 w/trocar

Primary DI
08034139294711
Brand
Round Drain type Jackson-Pratt Fr 19 w/trocar
Company
REDAX SPA
Model
24231
Catalog number
24231
Device description
The surgical drainage is a sterile and single-use device. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The product is compatible for use with gravity or suction drainage systems.
Published
2021-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBXCatheter, Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18034139294718PackageGS120In Commercial Distribution
08034139294711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803413929471818034139294718
08034139294711080341392947118034139294711

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable 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 variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, 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

Contacts#

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

Regulatory Flags#

DUNS number
338664915
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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

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Primary DI, Brand, Company table
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10080196995998MEDLINEMEDLINE INDUSTRIES, INC.GBX2024-12-12
10080196128839MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10080196997633MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
08034139292823Thoracic Catheter, Straight Fr 18REDAX SPAGBX2021-05-07
08034139292830Thoracic Catheter, Straight Fr 21REDAX SPAGBX2021-05-07
08034139292847Thoracic Catheter, Straight Fr 24REDAX SPAGBX2021-05-07
08034139292861Thoracic Catheter, Straight Fr 30REDAX SPAGBX2021-05-07