FDA.report

INVAC®

Primary DI
00650551038078
Brand
INVAC®
Company
PMT CORPORATION
Model
3102-3
Catalog number
3102-3
Device description
IN-LINE SURGICAL SUCTION CONTROL VALVE, MACRO SURGICAL SIZE - LARGE, BARBED
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00650551038078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551038078006505510380786505510380780650551038078

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.

Device Sizes

TypeValueUnit
Outer Diameter0.32Inch

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature58 Degrees Fahrenheit78 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
800-626-5463intl@pmtcorp.com

Regulatory Flags

DUNS number
039576871
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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