DEVICE: Lipogems Sport Medicine Kit 240 + Tray (08058773563019)

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If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Device Identifier (DI) Information

Lipogems Sport Medicine Kit 240 + Tray
LG MK 240 T
In Commercial Distribution
LG MK 240 T
LIPOGEMS INTERNATIONAL SPA
08058773563019
GS1

1
431081002 *Terms of Use
Lipogems Sport Medicine Kit 240cc + Tray
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
56627 Autologous adipose tissue noninvasive processing set
A noninvasive collection of non-powered devices designed as a closed system for the collection and processing (e.g., filtering, washing) of autologous fat tissue for reinjection into the patient from whom it was taken (autologous lipotransfer) for aesthetic body contouring. It consists of containers (typically filtration and waste collection bags) and connection accessories (e.g., connectors, tubing); it does not include invasive needles/cannulae. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
No Product Codes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

f0b80f34-d1d3-4fc4-92dc-ba6b08b98a2e
July 21, 2025
2
March 20, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
18058773673012 6 08058773563019 In Commercial Distribution 6 Boxes Carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+390237072408
info@lipogems.com
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