FDA.reportPublic FDA data

Irrigation set w/ flushing system for laser vaporization

Primary DI
03700512921509
Brand
Irrigation set w/ flushing system for laser vaporization
Company
Promepla
Model
GL0301L
Catalog number
GL0301L
Published
2016-09-14
Public version status
Update
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
GBXCatheter, Irrigation

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700512911500PackageGS115In Commercial Distribution
03700512921509PackageGS14In Commercial Distribution
03700512901501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700512911500037005129115003700512911500
03700512921509037005129215093700512921509
03700512901501037005129015013700512901501

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+37797984232customer@rocamed.eu

Regulatory Flags#

DUNS number
401020409
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700512925064Irrigation TubeOSG03399E5ST35Y9001972024-10-24
03700512925071Irrigation TubeOSG03499ST35C8237522024-10-24
03700512915263Irrigation TubeODG05599E5ST35Y15000702024-10-24
03700512921967Y-CLIC ADAPTER09-0197ROMYCLICST2282018-08-20
03700512987451LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.22cm, without wire09-0124ROJS9522ST2282018-08-20
03700512987468LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.24cm, without wire09-0125ROJS9524ST2282018-08-20
03700512987475LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.26cm, without wire09-0126ROJS9526ST2282018-08-20
03700512987482LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.28cm, without wire09-0127ROJS9528ST2282018-08-20
03700512987499LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.30cm, without wire09-0128ROJS9530ST2282018-08-20
03700512987505LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.24cm, without wire09-0129ROJS9624ST2282018-08-20
03700512977513LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.26cm, without wire09-0130ROJS9626ST2282018-08-20
03700512987529LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.28cm, without wire09-0131ROJS9628ST2282018-08-20
03700512987536LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.30cm, without wire09-0132ROJS9630ST2282018-08-20
03700512987543LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.24cm, without wire09-0133ROJS9724ST2282018-08-20
03700512987550LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.26cm, without wire09-0134ROJS9726ST2282018-08-20
03700512987567LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.28cm, without wire09-0135ROJS9728ST2282018-08-20
03700512987574LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.30cm, without wire09-0136ROJS9730ST2282018-08-20
03700512987581LumaFlex Double J stent, 2 open tips, Ch/Fr8/L.24cm, without wire09-0137ROJS9824ST2282018-08-20
03700512987598LumaFlex Double J stent, 2 open tips, Ch/Fr8/L.26cm, without wire09-0138ROJS9826ST2282018-08-20
03700512987604LumaFlex Double J stent, 2 open tips, Ch/Fr8/L.28cm, without wire09-0139ROJS9828ST2282018-08-20

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