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Intragraft Fat Disposable Kit for Autologous Adipose Tissue Harvesting and Sizi…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref KIG1-01
Identity
- Trade Name
- Intragraft Fat Disposable Kit for Autologous Adipose Tissue Harvesting and Sizing EUDAMEDTulip GEMS™ Single-Use FDA UDI
- Generic Name
- Liposuction system cannula, reusable FDA UDI
- Device Name
- Intragraft Fat Disposable Kit for Autologous Adipose Tissue Harvesting and Sizing EUDAMEDFDA UDI
- Model / Reference
- KIG1-01 EUDAMEDKIG1 FDA UDI
- Description
- Intragraft Fat Disposable Kit for Autologous Adipose Tissue Harvesting and Sizing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00819127024246 EUDAMEDFDA UDI
- Basic UDI-DI
- 081912702KIG17C EUDAMED
- Direct Marketing DI
- 00819127024246 EUDAMED
- FDA Product Code
- QPB FDA UDI
- EMDN Code
- K01020110 MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Liposuction system cannula, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5040 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Intragraft Fat Disposable Kit for Autologous Adipose Tissue Harvesting and Sizi… by Tulip Medical Products, Inc. — Class IIa — MDR, FDA UDI — listed in…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081912702KIG17C | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Tulip Medical Products, Inc.
- EUDAMED SRN
- US-MF-000049097
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 8dd063a9-036b-459d-8834-fb1ec2c2e374 61 fields · synced Oct 6, 2026
- FDA UDI e3a72cf1-0865-4c12-842b-862191a0a875 34 fields · synced May 27, 2026