FDA.report

FLOVAC

Primary DI
20653405034749
Brand
FLOVAC
Company
Conmed Corporation
Model
60-6005-500
Catalog number
60-6005-500
Device description
FLOVAC HANDCONTROLLED SUCTION/IRRIGATION
Published
2016-09-24
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
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20653405034749PackageGS110In Commercial Distribution
30653405034746PrimaryGS10
00653405034745Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340503474920653405034749
3065340503474630653405034746
00653405034745006534050347456534050347450653405034745

GMDN Terms

TermDefinition
Surgical irrigation/aspiration handpiece control valveA sterile device designed as a push-button valve that is inserted into the control valve seat of a reusable surgical irrigation/aspiration handpiece and when activated by the operator will interrupt the aspiration (suction) and activate the irrigation function (the fluid flow) of the handpiece/system. This provides a high level of hygiene as this device is removed after each application and discarded negating complicated and time-consuming cleaning procedures. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags

DUNS number
071595540
Device count
10
DM exempt
false
Premarket exempt
false
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
true

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