FDA.reportPublic FDA data

Lipogems Process Device 120 O

Primary DI
08058773562760
Brand
Lipogems Process Device 120 O
Company
LIPOGEMS INTERNATIONAL SPA
Model
LGD 120
Catalog number
LGD 120 O
Device description
Lipogems process device 120cc Ortho
Published
2023-03-20
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUUSystem, Suction, Lipoplasty
QKLLipoaspirate Washing System For Aesthetic Body Contouring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2
QKLLipoaspirate Washing System For Aesthetic Body ContouringGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK2207120

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2207120

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058773562760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058773562760080587735627608058773562760

GMDN Terms#

Term, Definition table
TermDefinition
Autologous adipose tissue collection/washing setA collection of sterile devices designed as a closed system for the harvesting and rapid treatment of autologous fat tissue for reinjection back into the patient from which it was taken for aesthetic body contouring. It typically consists of various chambers (e.g., a collection bag, waste material bag, and a cleaned tissue bag), flexible tubing, an intravenous (IV) spike for connection to the washing solutions, and a contiguous filter mesh which dialyses the fat graft. It is used in conjunction with appropriate IV solutions within the sterile field of intervention for plastic and reconstructive surgery and cosmetic surgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume120Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390237072408info@lipogems.com

Regulatory Flags#

DUNS number
431081002
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08058773560674Lipogems Ortho Kit 60LG OK 60LG OK 602023-03-20
08058773561800Lipogems Ortho Kit 240LG OK 240LG OK 2402023-03-20
08058773561817Lipogems Beauty Kit 60LG BK 60LG BK 602023-03-20
08058773561824Lipogems Beauty Kit 240LG BK 240LG BK 2402023-03-20
08058773562210Lipogems Surgery Kit 240LG SK 240LG SK 2402023-03-20
08058773562227Lipogems Surgery Kit 60LG SK 60LG SK 602023-03-20
08058773562470Lipogems Sport Medicine Kit 240LG MK 240LG MK 2402023-03-20
08058773562487Lipogems Sport Medicine Kit 60LG MK 60LG MK 602023-03-20
08058773562906Lipogems Surgery Kit 60 + TrayLG SK 60 TLG SK 60 T2023-03-20
08058773562913Lipogems Surgery Kit 120 + TrayLG SK 120 TLG SK 120 T2023-03-20
08058773562920Lipogems Surgery Kit 240 + TrayLG SK 240 TLG SK 240 T2023-03-20
08058773562944Lipogems Ortho Kit 120 + TrayLG OK 120 TLG OK 120 T2023-03-20
08058773562951Lipogems Ortho Kit 240 + TrayLG OK 240 TLG OK 240 T2023-03-20
08058773562968Lipogems Beauty Kit 60 + TrayLG BK 60 TLG BK 60 T2023-03-20
08058773562975Lipogems Beauty Kit 120 + TrayLG BK 120 TLG BK 120 T2023-03-20
08058773562982Lipogems Beauty Kit 240 + TrayLG BK 240 TLG BK 240 T2023-03-20
08058773562999Lipogems Sport Medicine Kit 60 + TrayLG MK 60 TLG MK 60 T2023-03-20
08058773563002Lipogems Sport Medicine Kit 120 + TrayLG MK 120 TLG MK 120 T2023-03-20
08058773563019Lipogems Sport Medicine Kit 240 + TrayLG MK 240 TLG MK 240 T2023-03-20
08058773562746Lipogems Process Device 120 BLGD 120LGD 120 B2023-03-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08681877009116Lipocube HybridSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009345Lipocube Hybrid ISTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009826Lipocube Hybrid MiniSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
00810130455843Medco ManufacturingMedco Manufacturing LLCMUU2026-03-31
00850034511047Puregraft SYNCBimini Technologies LLCQKL2026-02-24
08800052308909FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
00850034511023Puregraft 850 System Twin PackBimini Technologies LLCQKL2024-08-22
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
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07612367003568Quiver 480mmMedela AGMUU2024-05-31
07612367003698Overflow protection deviceMedela AGMUU2024-05-31
07612367003735Reusable serial connectorMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGMUU2024-05-31
07612367003896Tubing holder left sideMedela AGMUU2024-05-31
07612367003902Tubing holder right sideMedela AGMUU2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGMUU2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGMUU2024-05-31
07612367004695Holder for 1L/1.5L jar, rightMedela AGMUU2024-05-31
07612367004701Holder for 2L/2.5L jar, leftMedela AGMUU2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGMUU2024-05-31
07612367008242Double conical coupling pieceMedela AGMUU2024-05-31
07612367008655Silicone tube, ID 7mm, 33cmMedela AGMUU2024-05-31
07612367009928Y-pieceMedela AGMUU2024-05-31
07612367011204Vario Filter set, bacteria & overflowMedela AGMUU2024-05-31
07612367011372Single set 1lMedela AGMUU2024-05-31
07612367011389Single set 2lMedela AGMUU2024-05-31
07612367017329Single set 1l, clampholderMedela AGMUU2024-05-31