Identity
- Trade Name
- AdipoSizer System FDA UDI
- Generic Name
- Autologous adipose tissue noninvasive processing set FDA UDI
- Device Name
- Fat microsizing unit. FDA UDI
- Model / Reference
- 90-1006 FDA UDI
- Description
- Fat microsizing unit. FDA UDI
Identifiers
- Catalog Number
- 90-1006 FDA UDI
- Primary DI / UDI-DI
- 00860005496730 FDA UDI
- FDA Product Code
- KDC FDA UDI
- GMDN Term
- Autologous adipose tissue noninvasive processing set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Autologous adipose tissue noninvasive processing set
AdipoSizer System by Syntr Health Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Autologous adipose tissue noninvasive processing set.
- Evulse — Innovative Med, Inc. · Class I
- Lipogems Beauty Kit 120 + Tray — LIPOGEMS INTERNATIONAL SPA
- Sientra Viality-1400 — Sientra, Inc. · Class II
- Lipogems Process Device 120 O — LIPOGEMS INTERNATIONAL SPA · Class II
- Lipogems Surgery Kit 60 — LIPOGEMS INTERNATIONAL SPA
- Lipogems Sport Medicine Kit 240 + Tray — LIPOGEMS INTERNATIONAL SPA
- Lipogems Sport Medicine Kit 240 — LIPOGEMS INTERNATIONAL SPA
- Evulse — Innovative Med, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Syntr Health Technologies, Inc.
Sources (1)
- FDA UDI 1810eedc-d394-4340-8729-9f1713f682f9 35 fields · synced Jun 6, 2026