FDA.reportPublic FDA data

iovera Smart Tip

Primary DI
00816287020170
Brand
iovera Smart Tip
Company
PACIRA CRYOTECH, INC.
Model
STT0801-5
Device description
SMART TIP (1X90MM), 5-PACK
Published
2023-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
00816287020187PrimaryGS10
00816287020170Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816287020187008162870201878162870201870816287020187
00816287020170008162870201708162870201700816287020170

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held cryosurgical system handpiece tipA sterile component of a hand-held cryosurgery system intended to be attached to the system handpiece to deliver liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to skin/subcutaneous tissues for cryotherapy applications (e.g., surgical ablation, cosmetic, analgesic). It is typically a closed-end needle intended to deliver focused cooling to the therapy site without destroying healthy tissues. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
799347229
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816287020101iovera Smart TipSTT0811-52023-06-15
00816287020132iovera Smart TipSTT0309-52023-06-15
00816287020200iovera Smart TipSTT2190-52023-06-15
00816287020224iovera Smart TipSTT2309-52023-06-15
00816287020279iovera Smart TipSTT2190STIM-52023-06-15

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
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
00816287020071ioveraPacira Pharmaceuticals, Inc.GXH2020-02-12
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