FDA.reportPublic FDA data

MicroAire®

Primary DI
00847399015693
Brand
MicroAire®
Company
Microaire Surgical Instruments LLC
Model
PAL-408LLB
Device description
4mm BENT CANNULA, 10mm PORT, 30cm LONG, FLARED MERCEDES, SINGLE USE
Published
2016-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MUUSystem, Suction, Lipoplasty
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981922000LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRIMicroaire Surgical Instruments, Inc.1998-12-10QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847399015693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847399015693008473990156938473990156930847399015693

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction system cannula, single-useA rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length30Centimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103056420
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847399003591MicroAire® 2500-1002022-02-07
00847399003607MicroAire® 2500-2002022-02-07
00847399017406MicroAire®CART-CLAMP2025-08-01
00847399017413MicroAire® 70202025-08-01
00847399017420MicroAire® 7020-PAL2025-08-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGQPB2024-05-31
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
07612367003551Quiver 280mmMedela AGMUU2024-05-31
07612367003551Quiver 280mmMedela AGQPB2024-05-31
07612367003568Quiver 480mmMedela AGMUU2024-05-31
07612367003568Quiver 480mmMedela AGQPB2024-05-31
07612367003575Change over valveMedela AGQPB2024-05-31
07612367003698Overflow protection deviceMedela AGMUU2024-05-31
07612367003698Overflow protection deviceMedela AGQPB2024-05-31
07612367003735Reusable serial connectorMedela AGQPB2024-05-31
07612367003735Reusable serial connectorMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGQPB2024-05-31
07612367003896Tubing holder left sideMedela AGQPB2024-05-31
07612367003896Tubing holder left sideMedela AGMUU2024-05-31
07612367003902Tubing holder right sideMedela AGQPB2024-05-31
07612367003902Tubing holder right sideMedela AGMUU2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGQPB2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGMUU2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGMUU2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGQPB2024-05-31
07612367004695Holder for 1L/1.5L jar, rightMedela AGQPB2024-05-31
07612367004695Holder for 1L/1.5L jar, rightMedela AGMUU2024-05-31
07612367004701Holder for 2L/2.5L jar, leftMedela AGQPB2024-05-31
07612367004701Holder for 2L/2.5L jar, leftMedela AGMUU2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGQPB2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGMUU2024-05-31
07612367008242Double conical coupling pieceMedela AGQPB2024-05-31
07612367008242Double conical coupling pieceMedela AGMUU2024-05-31
07612367008655Silicone tube, ID 7mm, 33cmMedela AGMUU2024-05-31