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Cellfina System Cart

FDA UDI

Class II (US FDA UDI)

by Ulthera Inc

Identity

Trade Name
Cellfina System Cart FDA UDI
Generic Name
Operating table accessory trolley FDA UDI
Model / Reference
Rev R FDA UDI

Identifiers

Catalog Number
1010103 FDA UDI
Primary DI / UDI-DI
00840763101015 FDA UDI
510(k) Number
K161885 FDA UDI
FDA Product Code
OUP FDA UDI
GMDN Term
Operating table accessory trolley FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4790 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating table accessory trolley

Cellfina System Cart by Ulthera Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating table accessory trolley.

Cleared under the same submission

K161885 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ulthera Inc

Sources (1)

  • FDA UDI c95b9b5f-3d9b-4eaa-8513-1ebf828785ab 34 fields · synced Jun 8, 2026