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iovera Smart Tip

FDA UDI

Class II (US FDA UDI)

by Pacira Pharmaceuticals, INC

Identity

Trade Name
iovera Smart Tip FDA UDI
Generic Name
Hand-held cryosurgical system handpiece tip FDA UDI
Device Name
SMART TIP (1X90MM), 5-PACK FDA UDI
Model / Reference
STT2190-5 FDA UDI
Description
SMART TIP (1X90MM), 5-PACK FDA UDI

Identifiers

Primary DI / UDI-DI
00816287020217 FDA UDI
510(k) Number
K211334 FDA UDI
FDA Product Code
GXH FDA UDI
GMDN Term
Hand-held cryosurgical system handpiece tip 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Hand-held cryosurgical system handpiece tip

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

Similar devices

Also classified as Hand-held cryosurgical system handpiece tip.

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 7e1e5312-72d2-419b-b250-f5223b5d928c 34 fields · synced May 30, 2026