FDA.reportPublic FDA data

Lipogems Ortho Kit 240

Primary DI
18058773561807
Brand
Lipogems Ortho Kit 240
Company
LIPOGEMS INTERNATIONAL SPA
Model
LG OK 240
Catalog number
LG OK 240
Device description
Lipogems Ortho Kit 240
Published
2023-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18058773561807PackageGS16In Commercial Distribution
08058773561800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805877356180718058773561807
08058773561800080587735618008058773561800

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39023707248info@lipogems.com

Regulatory Flags#

DUNS number
431081002
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
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

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