FDA.reportPublic FDA data

SpineJet®

Primary DI
00853235007098
Brand
SpineJet®
Company
HYDROCISION, INC.
Model
56986
Catalog number
56986
Device description
SpineJet® Percutaneous Access straight Set-Diposable
Published
2017-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002764000HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURRHydrocision, Inc.2000-11-24HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853235007098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853235007098008532350070988532350070980853235007098

GMDN Terms#

Term, Definition table
TermDefinition
Water jet knife system handpiece, single-useA sterile, hand-operated device that is a component of a water jet knife system and designed to direct a concentrated stream of high-pressure water (typically sterile saline) to a surgical site to cut/dissect tissue. This handpiece is connected to a generator that pressurizes the water; it may also facilitate the aspiration of fluid and debris from the surgical site. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
834612764
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853235007005TenJet® 76000760002018-05-22
00853235007012TenJet®76400764002017-08-21
00853235007029TenJet®76700767002017-08-21
00853235007067SpineJet®56000560002017-08-25
00853235007326SpineJet® PerResector-China Version56000560002017-08-21
00853235007333HydroCision Console82700827002023-11-14
00853235007036SpineJet® 52320523202017-08-21
00853235007043HydroCision Console52700527002017-08-23
00853235007050SpineJet®55500555002017-08-21
00853235007074SpineJet®56110561102017-08-21
00853235007081SpineJet®56971569712017-08-21
00853235007104SpineJet® 56987569872017-08-21
00853235007111SpineJet®57162571622017-08-21
00853235007128SpineJet®57167571672017-08-21
00853235007135SpineJet® 57662576622017-08-21
00853235007142SpineJet®57667576672017-08-21
00853235007159SpineJet® 58162581622017-08-21
00853235007166SpineJet® 58163581632017-08-21
00853235007173SpineJet®58662586622017-08-21
00853235007180SpineJet®58663586632017-08-21

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Primary DI, Brand, Company table
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