FDA.report

High Volume Evacuator Tip

Primary DI
00616784221533
Brand
High Volume Evacuator Tip
Company
DYNAREX CORPORATION
Model
2215
Device description
High Volume Evacuator Tip, White
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EHZEvacuator, Oral Cavity

Product Code Classifications

CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784221533PackageGS110In Commercial Distribution
00616784221526PrimaryGS10
00616784221519Unit of UseGS10
00810180843430Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784221533006167842215336167842215330616784221533
00616784221526006167842215266167842215260616784221526
00616784221519006167842215196167842215190616784221519
00810180843430008101808434308101808434300810180843430

GMDN Terms

TermDefinition
Orthopaedic cement fume evacuatorA mains electricity (AC-powered) portable device designed to filter out and/or evacuate the toxic fumes produced during the preparation of orthopaedic cement [e.g., polymethylmethacrylate (PMMA)] before they can reach the environment. The device is a small enclosure with filters that remove the toxic vapors, diffusing the filtered air in the environment, or that may be connected to the hospital exhaustion system. This device is used mainly in operating rooms and other hospital areas during orthopaedic procedures that involve bone cement preparation.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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