FDA.reportPublic FDA data

iovera

Primary DI
00816287020071
Brand
iovera
Company
Pacira Pharmaceuticals, Inc.
Model
IST0221
Published
2020-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
GXHDevice, Surgical, Cryogenic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXHDevice, Surgical, CryogenicNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173763000iovera systemMyoscience, Inc.2018-02-28GXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816287020071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816287020071008162870200718162870200710816287020071

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held cryosurgical systemA hand-held assembly of electrically-powered devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to skin, subcutaneous, and/or mucosal tissues for cryotherapy applications (e.g., surgical ablation, cosmetic, analgesic). It typically includes a single-use or reusable handpiece with disposable application tip and cryogen cartridge (e.g., N2O cartridge), whereby the cryogen is delivered through the handpiece to the tip which is applied to tissues. It can be used for dedicated applications or across clinical specialties (e.g., general surgery, dermatology, neurology, orthopaedics, gynaecology).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117399934
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816287020118iovera Smart TipSTT0811-52023-06-15
00816287020149iovera Smart TipSTT0309-52023-06-15
00816287020187iovera Smart TipSTT0801-52023-06-15
00816287020217iovera Smart TipSTT2190-52023-06-15
00816287020231iovera Smart TipSTT2309-52023-06-15
00816287020286iovera Smart TipSTT2190STIM-52023-06-15
00816287020248ioveraIST22212023-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818788022295Epimed International, Inc.EPIMED INTERNATIONAL, INCGXH2025-12-05
10840143917004AtriCure cryoICE cryoXTATRICURE, INC.GXH2025-10-01
10840143912863AtriCure cryoICE cryoXTATRICURE, INC.GXH2025-04-25
30840143912867AtriCure cryoICE cryoXTATRICURE, INC.GXH2025-04-25
10840143911729AtriCure cryoICE cryoSPHERE+ Cryoablation SystemATRICURE, INC.GXH2024-02-15
10840143911736AtriCure cryoICE cryoSPHERE+ Cryoablation SystemATRICURE, INC.GXH2024-02-15
10840143911743AtriCure cryoICE cryoSPHERE MAX Cryoablation SystemATRICURE, INC.GXH2024-02-15
10840143911750AtriCure cryoICE cryoSPHERE MAX Cryoablation SystemATRICURE, INC.GXH2024-02-15
00816287020149iovera Smart TipPacira Pharmaceuticals, Inc.GXH2023-06-15
00816287020187iovera Smart TipPacira Pharmaceuticals, Inc.GXH2023-06-15
00816287020217iovera Smart TipPacira Pharmaceuticals, Inc.GXH2023-06-15
00816287020231iovera Smart TipPacira Pharmaceuticals, Inc.GXH2023-06-15
00816287020132iovera Smart TipPACIRA CRYOTECH, INC.GXH2023-06-15
00816287020170iovera Smart TipPACIRA CRYOTECH, INC.GXH2023-06-15
00816287020200iovera Smart TipPACIRA CRYOTECH, INC.GXH2023-06-15
00816287020224iovera Smart TipPACIRA CRYOTECH, INC.GXH2023-06-15
00816287020248ioveraPacira Pharmaceuticals, Inc.GXH2023-06-13
10840143902307cryoICE Cryoablation SystemATRICURE, INC.GXH2021-01-08
10840143902321AtriCure cryoICE Cryoablation System (CRYO2)ATRICURE, INC.GXH2021-01-08
10840143902543AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2021-01-08
10840143902550AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2021-01-08
30840143902608cryoICE Cryoablation SystemATRICURE, INC.GXH2021-01-08
30840143902646AtriCure cryoICE Cryoablation System (CRYO2)ATRICURE, INC.GXH2021-01-08
30840143902912AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2021-01-08
30840143902929AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2021-01-08
00818354017885AtriCure cryoICE Cryoablation System (CRYO2)ATRICURE, INC.GXH2020-03-18
00818354016321AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2018-11-15
00818354016338AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2018-11-15
00818354016123cryoICE Cryoablation SystemATRICURE, INC.GXH2018-04-01
00818788021908EpimedEPIMED INTERNATIONAL, INCGXH2017-10-27