FDA.reportPublic FDA data

MicroAire®

Primary DI
00847399015716
Brand
MicroAire®
Company
Microaire Surgical Instruments LLC
Model
PAL-R304LLB
Device description
3mm BENT CANNULA, 8mm PORT, 30cm LONG, MERCEDES, MULTI-USE
Published
2021-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K171286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171286000PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC2017-10-13QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847399015716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847399015716008473990157168473990157160847399015716

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length30Centimeter
Outer Diameter3Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
103056420
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
03701068807651FAT HARVESTING CANNULAAESTHETIC GROUPQPB2026-10-28
00810130457267Medco ManufacturingMedco Manufacturing LLCMUU2026-10-23
08800028800284SonoSculptNewpongQPB2026-10-13
07640306733177LipoSurg Artist Control UnitNouvag AGQPB2026-09-18
07640306733184LipoSurg Artist Handpiece S3Nouvag AGQPB2026-09-18
07640306733207LipoSurg Foot ControllerNouvag AGQPB2026-09-18
07640306733245LipoSurg Power Control UnitNouvag AGQPB2026-09-18
07640306733429LipoSurg Artist Standard SetNouvag AGQPB2026-09-18
07640306733436LipoSurg Power Standard SetNouvag AGQPB2026-09-18
B382SD6211530Surgical DirectSurgical Direct, Inc.MUU2026-08-03
00607151050627AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 3 ringsAPYX MEDICAL CORPORATIONQPB2026-06-26
00607151050634AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 26cm length, 3 ringsAPYX MEDICAL CORPORATIONQPB2026-06-26
00607151050641AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 1 ringAPYX MEDICAL CORPORATIONQPB2026-06-26
00840329838225BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.QPB2026-06-08
00607151050559AYON Ultrasound Assisted Liposuction HandpieceAPYX MEDICAL CORPORATIONQPB2025-05-29
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGQPB2024-05-31
07612367003551Quiver 280mmMedela AGQPB2024-05-31
07612367003551Quiver 280mmMedela AGMUU2024-05-31
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