FDA.report

MicroAire®

Primary DI
00847399003508
Brand
MicroAire®
Company
Microaire Surgical Instruments LLC
Model
201-00-50
Published
2016-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FQHLavage, Jet

Product Code Classifications

CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847399003508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847399003508008473990035088473990035080847399003508

GMDN Terms

TermDefinition
Surgical irrigation handpiece nozzleA sterile device designed to be attached to the distal end of a lavage system or kit handpiece to function as an applicator/nozzle that produces an intentional jet, stream or spray of sterile fluid (typically saline) from its aperture to the site of operation during a surgical intervention (e.g., trauma, soft tissue application and orthopaedic) for the purpose of removing tissue, bone debridement and/or bone cement residue, and to clean the site. It is available in many designs, shapes and sizes, including a fan spray, shower spray, high capacity with multiple aperture spray; some have a built-in filter, splash shield, or brush. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
103056420
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00847399017437MicroAire®5020-ASP2025-08-01
00847399017444MicroAire®7020-ASP2025-08-01
00847399017451MicroAire®7020-INF2025-08-01
00847399017468MicroAire®7020-PEDAL2025-08-01
00847399017475MicroAire® ASP-PUMP-1202025-08-01
00847399017482MicroAire® ASP-UI2025-08-01
00847399017499MicroAire® ASP-CBL2025-08-01
00847399017505MicroAire®ASP-FOOT2025-08-01
00847399017512MicroAire®ASP-FLTR22025-08-01
00847399017536MicroAire®CART2025-08-01
00847399017543MicroAire®CART-RING2025-08-01
00847399017550MicroAire®CART-IV-POLE2025-08-01
00847399018960MicroAire®ASP-TUBING2025-08-01
00847399019004MicroAire®CART-POLE2025-08-01
00847399019011MicroAire®CART-BASKET2025-08-01
00847399018984MicroAire®PAL-CASE2025-07-24
00847399018373MicroAire®PAL-7502023-10-02

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