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iovera

FDA UDI

Class II (US FDA UDI)

by Pacira Pharmaceuticals, INC

Identity

Trade Name
iovera FDA UDI
Generic Name
General cryosurgical system, cryogen gas, electronic FDA UDI
Device Name
SYSTEM FALCON IOVERA US FDA UDI
Model / Reference
IST2221 FDA UDI
Description
SYSTEM FALCON IOVERA US FDA UDI

Identifiers

Primary DI / UDI-DI
00816287020248 FDA UDI
510(k) Number
K211334 FDA UDI
FDA Product Code
GXH FDA UDI
GMDN Term
General cryosurgical system, cryogen gas, electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4250 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

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General cryosurgical system, cryogen gas, electronic

iovera by Pacira Pharmaceuticals, INC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General cryosurgical system, cryogen gas, electronic.

Cleared under the same submission

K211334 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pacira Pharmaceuticals, INC

Sources (1)

  • FDA UDI bb5d0f18-4634-4f83-bda0-0f436258a014 34 fields · synced May 30, 2026