NA

Primary DI
10818255010609
Brand
NA
Company
MICROVISION, INC.
Model
NA
Catalog number
5157
Device description
Associate Posterior Vitrectomy Probe, 25Ga, 2500CPM, 30psi
Published
2018-01-17
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
HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKPInstrument, Vitreous Aspiration And Cutting, Battery-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950287000UNIVIT PROBEMedical Instrument Development Laboratories, Inc.1995-04-10HKP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30818255010603PackageGS13In Commercial Distribution
10818255010609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081825501060330818255010603
1081825501060910818255010609

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy system micro-cutting unitA sterile, pneumatically-powered, hand-held cutting tool that incorporates a vitrectomy system handpiece, micro-tip and connecting tubing as a single unit, intended to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The tubing transmits pneumatic power produced by a system generator to the handpiece which converts this into a mechanical oscillating-cutting action at the tip. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.5Millimeter
Pressure30Pound per Square Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if packaging is damaged
Special Storage Condition, Specify00Keep away from direct sunlight
Special Storage Condition, Specify00Keep dry

Regulatory Flags#

DUNS number
013486803
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818255011194NAStyle 50354032017-12-22
10818255011200NAStyle 50454042017-12-22
10818255011217NAStyle 50554052017-12-22
10818255011224NAStyle 50654072017-12-22
10818255011231NAStyle 50754082017-12-22
10818255011323NAStyle 27754312017-12-22
10818255011330NAStyle 27954322017-12-22
10818255011378NAStyle 27654382017-12-22
10818255011385NAStyle 28654402017-12-22
10818255011392NAStyle 28754412017-12-22
10818255011415NAStyle 24054452017-12-22
10818255011422NAStyle 27054462017-12-22
10818255011439NAStyle 7054472017-12-22
10818255011446NAStyle 4854482017-12-22
10818255011453NAStyle 4054492017-12-22
10818255011460NAStyle 4254502017-12-22
10818255011491NAStyle 10654542017-12-22
10818255011521NAStyle 11254602017-12-22
30818255011198NAStyle 50354032017-12-22
30818255011204NAStyle 50454042017-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818255010432NAMICROVISION, INC.HKP2018-01-17
10818255010487NAMICROVISION, INC.HKP2018-01-17
10818255010708NAMICROVISION, INC.HKP2018-01-17
00812480010307NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2017-06-24
00812480010314NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2017-06-24
00852475007004Insight Instruments, Inc. Vitreous Biopsy Probe 27 GaINSIGHT INSTRUMENTS, INC.HKP2016-09-23
00852475007011Insight Instruments, Inc. Vitreous Biopsy Probe 27 GaINSIGHT INSTRUMENTS, INC.HKP2016-09-23
00856222004186INTRECTOR®INSIGHT INSTRUMENTS, INC.HKP2016-09-23
00856222004193INTRECTOR®INSIGHT INSTRUMENTS, INC.HKP2016-09-23
00856222004643INTRECTOR®INSIGHT INSTRUMENTS, INC.HKP2016-09-23
00856222004667RETRECTOR®INSIGHT INSTRUMENTS, INC.HKP2016-09-23
00812480010215NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2016-09-23
00812480010222NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2016-09-23
00812480010277NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2016-09-23
00812480010949NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2016-09-23
00812480010956NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2016-09-23
00812480010963NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2016-09-23
05050474520479AMO TAC VITRECTOMY HANDPIECEJOHNSON & JOHNSON SURGICAL VISION, INC.HKP2016-09-02
05050474520493AMO LIMBAL NEEDLE ASSEMBLYJOHNSON & JOHNSON SURGICAL VISION, INC.HKP2016-09-02
05050474520509AMO TAC INFUSION SLEEVEJOHNSON & JOHNSON SURGICAL VISION, INC.HKP2016-09-02