FDA.reportPublic FDA data

Tubing, sterile, for UHl smoke evacuation

Primary DI
04042761072649
Brand
Tubing, sterile, for UHl smoke evacuation
Company
Promepla
Model
WA95007A
Catalog number
ONG04299S1119
Published
2016-09-23
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

Product Codes#

Code, Name table
CodeName
FCZTube, Smoke Removal, Endoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCZTube, Smoke Removal, EndoscopicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
1404276107264PackageGS120In Commercial Distribution
04042761072649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404276107264014042761072641404276107264
04042761072649040427610726494042761072649

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

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
03700512905059Irrigation TubeOSG03399E5ST35Y9001972024-10-24
03700512905073Irrigation TubeOSG03499ST35C8237522024-10-24
03700512905196Irrigation TubeODG05599E5ST35Y15000702024-10-24
03700512925064Irrigation TubeOSG03399E5ST35Y9001972024-10-24
03700512925071Irrigation TubeOSG03499ST35C8237522024-10-24
03700512915263Irrigation TubeODG05599E5ST35Y15000702024-10-24
03700512901969Y-CLIC ADAPTER09-0197ROMYCLICST2282018-08-20
03700512963592BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cmROUS1235STROUS1235ST2016-10-03
03700512963608BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 45cmROUS1045STROUS1045ST2016-10-03
03700512963615BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cmROUS1245STROUS1245ST2016-10-03
03700512965589RocaFlex Access Sheath & Dilation Catheter 10/12x35cmAS101235AS1012352016-09-14
03700512965596RocaFlex Access Sheath & Dilation Catheter 12/14x35cmAS101245AS1012452016-09-14
03700512965602RocaFlex Access Sheath & Dilation Catheter 10/12x45cmAS121435AS1214352016-09-14
03700512965619RocaFlex Access Sheath & Dilation Catheter 12/14x45cmAS121445AS1214452016-09-14
03700512966197Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cm09-0015ROUS1035ST2017-11-09
03700512966203Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm09-0016ROUS1235ST2017-11-09
03700512966210Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm09-0017ROUS1045ST2017-11-09
03700512966227Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm09-0018ROUS1245ST2017-11-09
03700512967453LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.22cm, without wire09-0124ROJS9522ST2282018-08-20
03700512967460LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.24cm, without wire09-0125ROJS9524ST2282018-08-20

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00840306822889Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
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00840306822902Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822759Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-16
00840306822766Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-16
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