FDA.report

ENDOFLOW II - PROBES - 4 holes diam.5 inch

Primary DI
03700512920212
Brand
ENDOFLOW II - PROBES - 4 holes diam.5 inch
Company
Promepla
Model
OJG054504HDST12
Catalog number
OJG054504HDST12
Published
2016-10-11
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

Related Records

Contact Domains

Product Codes

CodeName
GBXCatheter, Irrigation

Product Code Classifications

CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03700512910213PackageGS110In Commercial Distribution
03700512920212PackageGS16In Commercial Distribution
03700512900214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03700512910213037005129102133700512910213
03700512920212037005129202123700512920212
03700512900214037005129002143700512900214

GMDN Terms

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

Contacts

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

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03700512987475LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.26cm, without wire09-0126ROJS9526ST2282018-08-20
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03700512987499LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.30cm, without wire09-0128ROJS9530ST2282018-08-20
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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
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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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