iovera Smart Tip

Primary DI
00816287020118
Brand
iovera Smart Tip
Company
Pacira Pharmaceuticals, Inc.
Model
STT0811-5
Device description
SMART TIP, STIMULATING (1X90MM), 5-PACK
Published
2023-06-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

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
00816287020118PrimaryGS10
00816287020101Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816287020118008162870201188162870201180816287020118
00816287020101008162870201018162870201010816287020101

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
117399934
Device count
5
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00816287020071ioveraIST02212020-02-12

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