FDA.reportPublic FDA data

SP6 Liposuction Kit includes MAS-10002, MAS-10003, MAS-10008

Primary DI
00850421007139
Brand
SP6 Liposuction Kit includes MAS-10002, MAS-10003, MAS-10008
Company
Millennium Medical Technologies, Inc.
Model
MAS-10009
Published
2023-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081039000LIPO CANNULAMillennium Medical Technologies, Inc.2008-07-10QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850421007139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850421007139008504210071398504210071390850421007139

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968286021
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000712478Autoclavable Suction Jar with Hose Barb extension - 250mLC-10250H2026-01-29
00850000712485Autoclavable Suction Jar with Hose Barb extension - 500mLC-10500H2026-01-29
00850000712492Autoclavable Suction Jar with Hose Barb extension - 1000mLC-101000H2026-01-29
00850000712508Autoclavable Suction Jar with Hose Barb extension - 2000mLC-102000H2026-01-29
00850000712515Autoclavable Suction Jar with Hose Barb extension - 3000mLC-103000H2026-01-29
00850000712119Disposable Fat Extraction cannula 3.4dis X 20cmMMT-D-100-202023-08-07
00850000712140Disposable Milli SuperG cannula 3.4mm X 20cm longMMT-D-100-3008500007121402023-08-07
00850000712164Disposable SuperG mini cannula 2.5mm X 20cm long, 12 holeMMT-D-100-52023-08-07
00850000712171Disposable cannula 2.5mm dia C 20cm long, 3 slotsMMT-D-100-62023-08-07
00850000712188Disposable cannula 2.0mm X 20cm long, 6 spiral slotsMMT-D-100-72023-08-07
00850000712195Disposable cannula 14ga X 10cm cupMMT-D-100-82023-08-07
00850000712249Super G Micro cannula 2.5mm X 250mm long, 300 holesMMT-D-SGM-252502023-08-07
00850000712157MMTIntellifat2023-06-12
00850000712201AirSculpt ConsoleAIRS-12025-06-04
00850000712379AirSculpt HandpieceAS-HP-100002025-06-04
00850000712430AirSculpt Triple-Port TubingAS-80002025-06-04
00850000712331AirSculpt SystemAIRS-1-SYS2025-06-03
00850000712461AirSculpt Air Hose (IN)TD-100102025-06-03
00850000712423Acquicell ProCMXPRO-5002025-04-24
00850000712096Infiltration Large Bore TubingFAT-10002-IN2023-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00607151051006AYON™ Power Liposuction Tubing AdaptorAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057008AYON™ Power Liposuction HandpieceAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057015AYON™ Power Liposuction CableAPYX MEDICAL CORPORATIONQPB2026-05-14
08800028800031LSSA (NP-200)NewpongQPB2026-05-06
03701416200035EUROMIEuromiQPB2025-08-27
03701416203388EUROMIEuromiQPB2025-08-27
03701416203401EUROMIEuromiQPB2025-08-27
00847399017413MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017420MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017437MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017444MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017451MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017468MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017475MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017482MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017499MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017505MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017512MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399018960MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
04260170880048WAL applicatorHuman Med AGQPB2025-07-30